(70 days)
Coagulation, vaporization, ablation or cutting of soft tissue in dermatology and plastic surgery, general surgery, podiatry and otorhinolaryngology.
The LS-40 CO2 Laser System is a microprocessor- controlled CO2 laser system using a sealed CO2 laser tube providing 40 watts maximum power. The system incorporates a CO2 laser tube within the main cabinet, an articulated arm beam delivery system and attachable laser accessories. The unit is activated for laser emission by a footswitch.
The provided text describes a 510(k) summary for the LS-40 CO2 Laser System, a medical device. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting detailed clinical studies with specific performance metrics for acceptance criteria.
Therefore, most of the requested information regarding acceptance criteria, study details, expert involvement, and ground truth establishment is not present in the provided document. The document primarily highlights the device's intended use and equivalence to a predicate device.
Here's an analysis based on the available information:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state acceptance criteria or report specific device performance metrics in the way one would expect for a diagnostic or AI-driven device. Clinical performance is not detailed, as the submission relies on substantial equivalence.
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not specified | Not specified |
2. Sample size used for the test set and the data provenance
Not applicable. The document describes a laser system, not an AI or diagnostic device that would typically involve a "test set" in the context of clinical data. The performance evaluation is based on engineering and safety standards, and equivalence to a predicate device, not a data-driven test set.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. Ground truth establishment with experts is not relevant for this type of device submission based on substantial equivalence to a predicate laser system.
4. Adjudication method for the test set
Not applicable. There is no test set or adjudication process described.
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
Not applicable. This is a laser surgical system, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a physical medical device, not an algorithm.
7. The type of ground truth used
Not applicable. Clinical ground truth (pathology, expert consensus, outcomes data) is typically used for diagnostic devices. For a surgical laser, ground truth would relate to its physical properties, safety, and functionality, which are assessed through engineering tests and comparison to a predicate device.
8. The sample size for the training set
Not applicable. This device is not an AI algorithm requiring a training set.
9. How the ground truth for the training set was established
Not applicable. This device is not an AI algorithm.
Conclusion from the provided information:
The LS-40 CO2 Laser System gained 510(k) clearance based on its substantial equivalence to the previously cleared LS-25 Family of CO2 Laser Systems (K040563). The submission primarily focuses on the device's technical specifications and intended use, demonstrating that it functions similarly and for the same indications as a legally marketed predicate device. This approach generally does not require new clinical studies demonstrating performance against specific acceptance criteria with clinical data, but rather relies on non-clinical performance data (e.g., electrical safety, electromagnetic compatibility, laser safety standards) and comparison to the predicate.
The "Performance Data: Results of Clinical Study:" section in the 510(k) summary (Attachment V) is empty, strongly suggesting that a clinical study with detailed performance metrics was not performed or was not necessary for clearance under the substantial equivalence pathway.
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Attachment V Special 510(K) Summary LS-40 CO2 Laser System
FEB 1 8 2010
The system
This 510(K) Summary of safety and effectiveness for the LS-40 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.
Mark Rohrer
CO2 Laser
footswitch.
None
None
105 Citation Street
Homewood, AL 35209
205-290-8251 - phone
LS-40 CO2 Laser System
79-GEX, 21 CFR 878-48
and otorhinolaryngology.
Instrument, Surgical, Powered, laser
LS-25 Family of CO2 Laser Systems K040563
providing 40 watts maximum power.
The LS-40 CO2 Laser System is a microprocessor-
controlled CO2 laser system using a sealed CO2 laser tube
incorporates a CO2 laser tube within the main cabinet, an articulated arm beam delivery system and attachable laser accessories. The unit is activated for laser emission by a
The LS-40 CO2 Laser System is intended to be used for
Coagulation, Vaporization, Ablation or cutting of soft tissue in dermatology and plastic surgery, general surgery, podiatry
December 2, 2009
Sandstone Medical Technologies, LLC Applicant:
Address:
Contact Person:
Telephone and Email:
Preparation Date:
Device Trade Name:
Common Name:
Classification Name:
Legally Marketed Predicate Device:
Description of the Enlyten System
Intended use of the Enlyten System:
Performance Data: Results of Clinical Study:
Conclusion:
The LS-40 CO2 Laser System is substantially equivalent to the previously cleared LS Family of CO2 Lasers that is in commercial distribution for use in Dermatology and Plastic Surgery.
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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with three lines representing its wings and body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Sandstone Medical Technologies, LLC % Mr. Mark Rohrer 105 Citation Court Homewood, Alabama 35209
FEB 1 8 2010
Re: K093793
Trade/Device Name: LS-40 CO2 Surgical 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: GEX Dated: January 18, 2010 Received: January 19, 2010
Dear Mr. Rohrer:
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 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 manutacturing practice requirements as set
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Page 2 - Mr. Mark Rohrer
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.
FOR
Sincerely yours.
M. N. McMillen
ACTING
DBORD DIR.
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
510(k) Number (if known): _
Device Name:
Indications for Use:
Coagulation, vaporization, ablation or cutting of soft tissue in dermatology and plastic surgery, general surgery, podiatry and otorhinolaryngology.
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) ·
Concurrence of CDRH, Office of Device Evaluation (ODE)
Michael P. O'Leary FOR M. MELKERSON
(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices
Page 1 of 1
510(k) Number K093793
§ 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.