(182 days)
Dermatological procedures requiring ablation, coagulation and resurfacing of soft tissue, including skin.
The eMatrix CO2 is a Fractional CO2 laser device intended for dermatological procedures requiring ablation, coagulation and resurfacing of soft tissue including skin. The device console houses the major units of the system that include the laser module, the power supply, the scanner and all other electrical components. Laser is transmitted to the tissue via a series of lens integrated into the articulated arm. The system parameters are controlled via a LCD touchscreen and proprietary SW.
Here's a breakdown of the acceptance criteria and study information based on the provided text, focusing on the performance evaluation of the eMatrix CO2 device.
1. Table of Acceptance Criteria and Reported Device Performance
The provided document does not explicitly state quantitative acceptance criteria in a numerical format often seen for diagnostic devices (e.g., sensitivity, specificity thresholds). Instead, the performance evaluation focuses on the device's ability to achieve its intended physical effects on tissue.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Device produces morphological changes consistent with ablation, coagulation, and resurfacing of soft tissue, including skin. | Performance Evaluation of skin biopsies revealed morphological changes, which were created under the impact of the eMatrix CO2 of skin resurfacing, as expressed via demarcated zones of ablation and coagulation. |
| Device demonstrates different impacts in depth and width based on treatment modes. | The different treatment modes led to a different impact in depth and width of the tissue. |
| Affected zones become deeper with increased energy levels. | The affected zones tended to become deeper as the level of energy employed was increased. |
| Device maintains a uniform fractional phenotype, leaving intact, non-affected tissue between treated spots. | The affected zone were of uniform fractional phenotype, leaving intact, non-affected tissue between treated spots. |
| Device meets labeled performance claims and is substantially equivalent to predicate devices. | Conclusion: We have demonstrated that the eMatrix CO2 meets its labeled performance claims, and that it is substantially equivalent to the predicate devices. (This is a summary statement based on the qualitative findings described above and comparison to predicates.) |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: The document only mentions "skin biopsies" being evaluated. It does not provide an explicit numerical sample size for the test set (e.g., number of biopsies, number of subjects).
- Data Provenance: Not specified in the provided text. It does not mention the country of origin of the data or whether the study was retrospective or prospective.
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 used or their qualifications for establishing ground truth. The evaluation mentions "morphological changes, which were created under the impact of the eMatrix CO2," implying a direct observation of the physical effects on tissue, likely by pathologists or histologists.
4. Adjudication Method for the Test Set
- The document does not describe any adjudication method (e.g., 2+1, 3+1). The evaluation appears to be a direct physical assessment of biopsy results.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
- No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not conducted or described. This type of study is more common for diagnostic imaging devices where human readers interpret results. The eMatrix CO2 is a therapeutic laser device, and its performance evaluation focused on its direct physical effects on tissue.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
- No, a standalone algorithm-only performance study was not conducted. The eMatrix CO2 is a physical medical device, not a software algorithm, so this type of study isn't applicable.
7. The Type of Ground Truth Used
- The ground truth used was based on histopathological examination of skin biopsies. The "morphological changes" and "demarcated zones of ablation and coagulation" observed in the biopsies served as the direct evidence (ground truth) of the device's effect.
8. The Sample Size for the Training Set
- The document describes a "Performance Evaluation of skin biopsies" which appears to be the primary study for demonstrating performance. There is no mention of a separate training set or any machine learning/AI component that would require one. The validation is based on the direct physical outcomes on the test biopsies.
9. How the Ground Truth for the Training Set Was Established
- As there is no mention of a training set for a machine learning model, this question is not applicable. The "ground truth" (histopathological observations) was established for the performance evaluation biopsies directly.
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NOV - 9 2010
510(K) Summary of Safety and Effectiveness
This summary of safety and effectiveness information is being submitted in accordance with the requirements of the SMDA 1990 and 21 CFR 807.92.
| Applicant name: | Syneron Medical Ltd.,Industrial Park, P.O.B. 550Yokneam Illit, 20692, Israel |
|---|---|
| Contact Person: | Avi HirshnzonVP of QA and Regulatory AffairsTel : + 972 54 330 3402, + 972 732 442 200, Ext. 254Fax : + 972 732 442 202E-mail : avih@syneron.com |
| Trade Name: | eMatrix CO2 |
| Common name: | CO2 laser system |
| Classification: | Name: powered laser surgical instrumentProduct Code: GEXRegulation No: 878.4810Class: IIClassification Panel: General & Plastic Surgery |
| Predicate Devices: | Substantial equivalence to the following predicate devices isclaimed:1. Fraxel III SR Laser System (Fraxel re:pair™) and accessoriesK071051; Reliant Technologies.2. Alma Lasers Family of THERMO-XEL Handpieces Pixel Models:2940, 1060 K072182; Alma Lasers3. Alma Lasers THERMO-XEL CO2 Laser System and DeliveryDevice Accessories K080463; Alma Lasers |
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Device description:
The eMatrix CO2 is a Fractional CO2 laser device intended for dermatological procedures requiring ablation, coagulation and resurfacing of soft tissue including skin. The device console houses the major units of the system that include the laser module, the power supply, the scanner and all other electrical components. Laser is transmitted to the tissue via a series of lens integrated into the articulated arm. The system parameters are controlled via a LCD touchscreen and proprietary SW.
Indication for Use Dermatological procedures requiring ablation, coagulation and Statement: resurfacing of soft tissue, including skin.
Performance Evaluation of skin biopsies revealed morphological changes, which validation: were created under the impact of the eMatrix CO2 of skin resurfacing, as expressed via demarcated zones of ablation and coagulation. The different treatment modes led to a different impact in depth and width of the tissue. The affected zones tended to become deeper as the level of energy employed was increased .The affected zone were of uniform fractional phenotype, leaving intact, non-affected tissue between treated spots.
Conclusion: . We have demonstrated that the eMatrix CO2 meets its labeled performance claims, and that it is substantially equivalent to the predicate devices
05/09/2010
Date
Avi Hirshzon
VP QA & Regulatory Affairs
Syneron Medical Ltd.
5-2
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Syneron Medical Ltd. % Mr. Avi Hirshnzon VP Quality Assurance and Regulatory Industrial Zone, Tavor Building Yokneam Illit 20692 P.O. Box 550, Israel
Re: K101321
Trade/Device Name: eMatrix CO2 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: November 04, 2010 Received: November 05, 2010
Dear Mr. Hirshnzon:
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. Please note: CDRH does not evaluate information related to contract linbility 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.
NOV - 9 2010
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Page 2 - Mr. Avi Hirshnzon
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 device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) 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/MedicalDevices/Safety/ReportaProblem/default.htm 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/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely vours.
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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Indications for Use
NOV - 9 2010
510(k) Number: K101321
Device Name: eMatrix CO2
Indications for Use:
Dermatological procedures requiring ablation, coagulation and resurfacing of soft tissue, including skin.
Over-The-Counter Use Prescription Use _ ______________________________________________________________________________________________________________________________________________________________________________ AND/OR (Part 21 CFR 801 Subpart D) (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence o Office of Device Evaluation (ODE)
Sign-Off) (Division Division of Surgical. Orthopedic, and Restorative Devices
510(k) Number K101321
§ 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.