(283 days)
The Equinox CO 2 laser when used in traditional non-fractionated scanner mode is indicated for incision, excision, ablation, vaporization, and coagulation of body soft tissues.
The Equinox CO 2 laser when used in fractionated mode is indicated for ablative skin resurfacing.
The Equinox CO2 laser has a wavelength of 10,600nm. CO2 fractional laser uses scanning optics to deliver a pattern of thermal energy to the epidermis and upper dermis. Device accessories include tip attachments. This system consists of main body, color touch screen, Arm, hand-piece and Foot switch.
The Equinox CO2 Laser System's performance for the fractionated mode was shown by histology data. The study involved using the device on a human arm with varying energy levels (10mJ, 40mJ, 70mJ per microbeam). The target area was then biopsied to evaluate the effect, specifically looking at the depth and width of thermal damage zones and the healing response over time.
Here's the breakdown of the information requested:
1. Table of Acceptance Criteria and Reported Device Performance
The submission does not explicitly state "acceptance criteria" in the traditional sense of pre-defined thresholds that the device must meet to be deemed acceptable. Instead, it presents the histology data from the study and then concludes that based on this data (and similar technology characteristics), the device is substantially equivalent to the predicate device. The performance data itself serves as the support for this claim of substantial equivalence for ablative skin resurfacing.
Therefore, the "acceptance criteria" can be inferred to be the demonstration of typical thermal damage and healing patterns consistent with fractional CO2 laser resurfacing, which the provided data aims to illustrate. The reported device performance is the histology data.
| Performance Metric | 10 mJ (Day 0) | 40 mJ (Day 0) | 70 mJ (Day 0) | 10 mJ (Day 3) | 40 mJ (Day 3) | 70 mJ (Day 3) | 70 mJ (Day 14) |
|---|---|---|---|---|---|---|---|
| Depth of Thermal Damage | 115.01 µm | 200.24 µm | 272.56 µm | 94.78 µm | 164.50 µm | 217.22 µm | 43.87 µm |
| Width of Thermal Damage | 347.30 µm | 358.75 µm | 362.13 µm | 293.71 µm | 313.20 µm | 334.49 µm | 95.28 µm |
(Note: Data for 10mJ and 40mJ at Day 14 were "X", indicating they were not provided or not relevant for the conclusion at those specific energy levels and time points in this summary.)
2. Sample Size Used for the Test Set and the Data Provenance
- Sample Size: The document states the device was "used on a human arm." It does not specify the number of subjects or the number of sites on the arm. It implies a single human subject ("a human arm").
- Data Provenance: The document does not explicitly state the country of origin. It is a retrospective report of a study that was conducted.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
The document does not provide details on the number or qualifications of experts used to establish the ground truth for the histology (e.g., who interpreted the biopsies). It simply states the target area "was biopsied to evaluate the effect."
4. Adjudication Method for the Test Set
The document does not describe any adjudication method.
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 MRMC study was done, as this is a laser device, not an AI diagnostic tool involving human readers.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
This refers to a standalone performance of the laser device itself, directly evaluating its physical effects on tissue, which is precisely what the histology study represents. The device's performance was assessed based on the direct results (thermal damage depth and width) in the biological tissue.
7. The Type of Ground Truth Used
The ground truth used was histology from biopsied tissue. This is considered objective biological evidence of the device's effects on human skin.
8. The Sample Size for the Training Set
The document does not mention a training set. This is a medical device performance study, not an AI model requiring separate training data.
9. How the Ground Truth for the Training Set was Established
Not applicable, as there is no training set for this type of device performance study.
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Attachment 5 510(K) Summary Equinox CO2 Laser System
Pg 1 of 2
This 510(K) Summary of safety and effectiveness for the Equinox CO2 laser System is submitted in accordance with the requirements of the SMDA 1990 and following guidance concerning the organization and content of a 510(K) summary.
| Applicant: | Eclipsemed Global, Inc |
|---|---|
| Address: | 16850 Dallas ParkwayDallas, TX 75248972-380-2911 - phone972-380-2953 - fax |
| Contact Person: | Mr. Tom O'Brien |
| Telephone: | 972-380-2911 - Phone |
| Fax: | 972-380-2953 - Fax |
| Email: | tobrien@eclipsemed.com |
| Preparation Date: | February 15, 2010 |
| Device Trade Name: | Equinox CO2 Laser System |
| Common Name: | CO2 Laser |
| Classification Name: | Instrument, Surgical, Powered, laser79-ONG, 21 CFR 878-4810 |
| Legally Marketed Device: | Predicate Cynosure Affirm CO2 LaserK081424 |
| Description of the Equinox CO2 laser | The Equinox CO2 laser has a wavelength of 10,600nm. CO2fractional laser uses scanning optics to deliver a pattern of thermalenergy to the epidermis and upper dermis. Device accessoriesinclude tip attachments. This system consists of main body, colortouch screen, Arm, hand-piece and Foot switch. |
| Intended use of the Equinox CO2 laser | The Equinox CO 2 laser when used in traditional non-fractionatedscanner mode is indicated for incision, excision, ablation,vaporization, and coagulation of body soft tissues.The Equinox CO 2 laser when used in fractionated mode isindicated for ablative skin resurfacing. |
| Performance Data: | Histology data was submitted to support clearance of the device infractionated mode. The device was used on a human arm withenergy up to 70mJ per microbeam and the target area wasbiopsied to evaluate the effect. The data was to show the depthand width of thermal damage zones and healing response overtime. The following table shows the width and depth ofpenetration on the day of treatment, day 3 post treatment and day14 post treatment. |
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K100487 pg 2 of 2
Attachment 5 510(K) Summary Equinox CO2 Laser System
| 10 mJ | 40 mJ | 70 mJ | ||||
|---|---|---|---|---|---|---|
| Day | Depth | Width | Depth | Width | Depth | Width |
| 0 | 115.01 µm | 347.30 µm | 200.24 µm | 358.75 µm | 272.56 µm | 362.13 µm |
| 3 | 94.78 µm | 293.71 µm | 164.50 µm | 313.20 µm | 217.22 µm | 334.49 µm |
| 14 | X | X | X | X | 43.87 µm | 95.28 µm |
Results of Clinical Study:
None
Conclusion:
The Equinox CO2 Laser System is substantially equivalent to the Cynosure Affirm CO2 Laser cleared in K081424. The Equinox CO2 Laser System in non-fractionated scanner mode is substantially equivalent in terms of indication for use and technology based on similar technical characteristics. The Equinox CO2 Laser System in fractionated mode is substantially equivalent to the predicate device in terms of indications for use and technology based on similar technology characteristics as well as the provided histology data.
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Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird-like symbol with three curved lines forming its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the symbol. The text is in all capital letters and is evenly spaced around the circle.
"NOV 2 9 2010
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Eclipsemed Global, Inc. % Ms. Connie Hoy 16850 Dallas Parkway Dallas, Texas 75248
Re: K100487
Trade/Device Name: Equinox CO2 Laser System 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, GEX Dated: November 19, 2010 Received: November 22, 2010
Dear Ms. Hoy:
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 liability 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.
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
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Page 2 - Ms. Connie Hoy
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 (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/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
Sincerely, yours,
Mark A. Millen
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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pg 1 of (
Indications for Use
510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
NOV 2 9 2010
Device Name : Equinox CO2 Laser System
The Equinox CO 2 laser when used in traditional non-fractionated scanner mode is indicated for incision, excision, ablation, vaporization, and coagulation of body soft tissues.
The Equinox CO 2 laser when used in fractionated mode is indicated for ablative skin resurfacing.
Prescription Use XX (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)
Concurr e of Device Evaluation (ODE) (Division Sign-Off) Page 1 of 1 Division of Surgical, Orthopedic, and Restorative Devices
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.