(434 days)
The NaturaLase CO2 Laser System is indicated for use in dermatological procedures requiring ablation (removal), resurfacing or coagulation of soft tissue.
The NaturaLase CO2 is an RF excited CO2 laser. The laser energy is delivered through an articulated arm and with a scanner that distributes the laser energy on the skin in a controlled way with uniform distribution. The scanner design allows the system to ablate small micro spots of tissue. The system has the ability to deliver micro spots with a size of 120 microns and up to 45 mJ of optical energy per micro spot.
The NaturaLase CO2 Laser is a medical device, and this document does not contain information on acceptance criteria or a study that proves the device meets specific performance criteria in the way artificial intelligence models are typically evaluated.
Instead, this is a 510(k) summary for premarket notification to the FDA, demonstrating substantial equivalence to a predicate device (Lutronic Mosaic eCO2 Laser System). For such devices, the "acceptance criteria" are generally that the device has the same intended use and fundamental technology as a legally marketed predicate device, and that it raises no new issues of safety and effectiveness.
Here's an analysis based on the provided text, addressing the points where information is available or relevant:
1. A table of acceptance criteria and the reported device performance
Since this is a medical device submission for substantial equivalence rather than an AI model evaluation, "acceptance criteria" are not reported as quantitative metrics with specific thresholds and device performance results in the same way. Instead, the "acceptance" is based on demonstrating equivalence to an existing, legally marketed device.
| Acceptance Criterion (Implicit for 510(k) Equivalence) | Reported Device Performance |
|---|---|
| Intended Use Equivalence: Same indications for use as the predicate device. | The NaturaLase CO2 Laser System is indicated for use in dermatological procedures requiring ablation (removal), resurfacing or coagulation of soft tissue, which is stated to be the same intended use as the predicate device - Lutronic Mosaic eCO2 Laser System (K080496). |
| Technological Equivalence: Uses the same fundamental technology and similar design principles as the predicate device. | Both systems use "similar RF excited CO2 laser tubes with the energy delivered through an articulated arm and a scanner. Both use a 120 micron micro spot and have various scanner patterns that deliver ablative fractional resurfacing." The NaturaLase CO2 is described as an "RF excited CO2 laser" with energy delivered via an articulated arm and scanner, ablating small micro spots of tissue (120 microns, up to 45 mJ). |
| Safety and Effectiveness: Does not raise new issues of safety and effectiveness compared to the predicate device. | Histology data was collected to demonstrate performance, verify healing rate, and characterize the micro spot at various energy settings. "The wounds and the healing process showed an excellent correlation with literature and with the control laser." This supports the claim that the device is safe and effective and does not raise new issues. The conclusion states: "Histology data confirmed the treatment parameters and the safety and effectiveness of the laser. It raises no new issues of safety and effectiveness..." |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size: The document mentions "laser treatment of human skin" for histology data, but does not specify the number of human subjects or punch biopsies in the study.
- Data Provenance: The data is from "human skin," implying it's prospective ("treated" human skin). The country of origin is not specified, but the applicant (Focus Medical) is based in Bethel, CT, USA.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This type of information is not applicable to this document. The study described focuses on objective histological measurements (spot size, treatment depth, healing process) of laser effects on tissue, not on subjective interpretations requiring expert consensus for ground truth.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable. The study involves objective measurements of tissue response, not interpretive assessments that would require adjudication.
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
This is not applicable. This document describes a medical device (laser system), not an AI algorithm. Therefore, an MRMC study related to AI assistance for human readers was not performed.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is not applicable. This describes a physical medical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The ground truth for the "histology data" study was based on objective measurements derived from punch biopsies, which falls under pathology/histology. These measurements included "spot size, treatment depth and the healing process."
8. The sample size for the training set
This is not applicable. This document describes a medical device, not a machine learning model, so there is no concept of a "training set" in this context.
9. How the ground truth for the training set was established
This is not applicable for the same reasons as point 8.
{0}------------------------------------------------
0333 . Pg 1 of
Focus Medical NaturaLase CO2 510(k) Submission
510(K) SUMMARY 5.
ﺔ ﻳ
APR 1 2 2012
| Applicant: | Focus Medical23 Francis J. Clarke CircleBethel, CT 06801203-730-8885 |
|---|---|
| Manufacturer: | Focus Medical23 Francis J. Clarke CircleBethel, CT 06801 |
| Contact Person: | Mr. John B. Lee, Jr.PresidentFocus Medical |
| Name of the Device: | NaturaLase CO2 LaserRegulation Number: 21 CFR 878.4810Regulation Name: Laser surgical instrument for use in general and plasticsurgery and in dermatologyRegulatory Class: Class IIProduct Code: ONG |
| Predicate Device: | Lutronic Mosaic eCO2 Laser System (K080496) |
| Device Description: | The NaturaLase CO2 is an RF excited CO2 laser. The laser energy isdelivered through an articulated arm and with a scanner that distributesthe laser energy on the skin in a controlled way with uniform distribution.The scanner design allows the system to ablate small micro spots oftissue. The system has the ability to deliver micro spots with a size of 120microns and up to 45 mJ of optical energy per micro spot. |
| Indications for Use: | The NaturaLase CO2 Laser System is indicated for use indermatological procedures requiring ablation (removal), resurfacingor coagulation of soft tissue. |
| Substantial Equivalence: | The NaturaLase CO2 has the same intended use as the predicate device-Lutronic Mosaic eCO2 Laser System (K080496). It uses the samefundamental technology as the predicate device. Both systems usesimilar RF excited CO2 laser tubes with the energy delivered through anarticulated arm and a scanner. Both use a 120 micron micro spot andhave various scanner patterns that deliver ablative fractional resurfacing. |
| Histology Data: | Histology data was collected to demonstrate the performance of the laser.The study included laser treatment of human skin to verify the healing rateand the characteristics of the micro spot at various energy settings.Punch biopsies were used to measure spot size, treatment depth and thehealing process over a three week period. The wounds and the healingprocess showed an excellent correlation with literature and with thecontrol laser. |
| Conclusion: | The specifications, indications for use and performance of the NaturaLaseCO2 Laser is substantially equivalent to the legally marketed predicatedevice. Histology data confirmed the treatment parameters and the safetyand effectiveness of the laser. It raises no new issues of safety andeffectiveness and should be approved for marketing under the generalcontrols provisions of the Federal Food, Drug, and Cosmetic Act. |
{1}------------------------------------------------
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. In the center of the circle is an abstract symbol that resembles an eagle or bird in flight.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
APR 1 2 2012
Focus Medical % Mr. John B. Lee, Jr. President 23 Francis J. Clarke Circle Bethel. Connecticut 06801
Re: K110333
Trade/Device Name: NaturaLase 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: II Product Code: ONG Dated: March 20, 2012 Received: April 3, 2012
Dear Mr. Lee:
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 piemarket 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
{2}------------------------------------------------
Page 2 - Mr. John B. Lee, Jr.
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/CDRH0ffices/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 yours.
iely yours,
Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
{3}------------------------------------------------
Focus Medical NaturaLase CO2 510(k) Submission
110333 pg1. of 1
INDICATIONS FOR USE STATEMENT 4.
Intended Use Statement
The NaturaLase CO2 Laser System is indicated for use in dermatological procedures requiring ablation (removal), resurfacing or coagulation of soft tissue.
Prescription Use (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 IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE) The
Neil R. Doyle for nxm
(Division Sign-Off) (Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K110333
Confidential
§ 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.