(103 days)
The scanning handpiece is intended to be used as an accessory to the LS Family of CO2 Lasers to deliver the laser light to the targeted area for skin resurfacing in a fractionated manner.
The LS Family of CO2 lasers are microprocessor-controlled laser systems that incorporate a handpiece to deliver energy to the tissue in a scanned, fractionated pattern.
The provided document describes a 510(k) submission for the LS Family of CO2 Lasers with a Scanning Handpiece. The focus of this submission is to demonstrate substantial equivalence to a previously cleared device (LS Family of CO2 Lasers cleared under K040563), rather than to establish novel performance criteria through a standalone study.
Therefore, many of the requested categories related to acceptance criteria, specific device performance metrics, and a detailed study design with sample sizes, expert ground truth, and comparative effectiveness are not applicable or not explicitly detailed in this type of regulatory document.
However, based on the information provided, here's a breakdown of what can be extracted:
1. Table of Acceptance Criteria and Reported Device Performance:
- Acceptance Criteria: The primary acceptance criterion for this 510(k) submission is substantial equivalence to the predicate device (LS Family of CO2 Lasers cleared under K040563). This means that the new device (with the additional scanning handpiece) should perform as safely and effectively as the predicate device for its intended use. Specific quantitative performance metrics for "acceptance" are not explicitly listed, as the general approach is comparison to an already approved device.
- Reported Device Performance: The document states "Histology was collected from a small sample of patients to determine the depth of penetration." This indicates that the performance evaluated was the ability of the device, specifically the scanning handpiece, to achieve a certain depth of penetration in tissue, which is relevant to skin resurfacing. However, the specific "reported device performance" values or ranges (e.g., average depth of penetration, variability) are not provided in this summary. Instead, the conclusion is that the device "is substantially equivalent."
| Feature/Metric | Acceptance Criteria (Implicit for Substantial Equivalence) | Reported Device Performance (from Histology) |
|---|---|---|
| Safety | Equivalent to predicate device (K040563) | Not explicitly detailed in this summary |
| Effectiveness | Equivalent to predicate device (K040563) for intended use | Achieved depth of penetration |
| Depth of Penetration | Not explicitly defined, but assumed to be consistent with predicate for intended use | Determined via histology |
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size: "a small sample of patients." The exact number is not specified.
- Data Provenance: The study involved human patients, implying
- Country of Origin: Not specified but typically assumes the location of the submitting company or clinical sites.
- Retrospective or Prospective: Not explicitly stated, but clinical studies for such submissions are typically prospective to evaluate new features.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
- Number of Experts: Not specified.
- Qualifications of Experts: Not specified, but for histological analysis, it would typically be a pathologist.
4. Adjudication Method for the Test Set:
- Adjudication Method: Not specified. For histological analysis, typically an independent pathologist would review the samples.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done:
- MRMC Study: No, an MRMC comparative effectiveness study was not mentioned or conducted. The study performed was to determine depth of penetration, not a comparative study with human readers.
- Effect Size of AI vs. Without AI Assistance: Not applicable, as this device is a laser system, not an AI-powered diagnostic tool, and there were no human reader studies.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Standalone Performance: Not applicable. This device is a laser system, not an algorithm. The "performance data" mentioned refers to the physical effects of the laser on tissue, not an algorithm's output.
7. Type of Ground Truth Used:
- Ground Truth: Histology was used as the ground truth to determine the depth of penetration. This is a direct measurement from tissue analysis.
8. Sample Size for the Training Set:
- Sample Size: The document does not mention a training set in the context of a machine learning algorithm. The "small sample of patients" was used for performance data (histology).
9. How the Ground Truth for the Training Set Was Established:
- Ground Truth Establishment: Not applicable, as there is no mention of a training set for an algorithm. The histological ground truth for the performance study was established through laboratory analysis of patient tissue samples.
{0}------------------------------------------------
Attachment III 510(K) Summary LS Family of CO2 Lasers with Fractionated Handpiece
082101
This 510(K) Summary of safety and effectiveness for the LS Family of CO2 Lasers is submitted in accordance with the requirements of the SMDA 1990 and the following guidance concerning the organization and content of a 510(K) summary.
| Applicant: | Sandstone Medical Technologies, LLC |
|---|---|
| Address: | Sandstone Medical Technologies, LLC105 Citation CourtHomewood, Alabama 35209 |
| Contact Person: | Mark Rohrer |
| Telephone: | 1-205-290-8251- Phone |
| Preparation Date: | July 20, 2008 |
| Device Trade Name: | LS Family of CO2 Lasers |
| Common Name: | CO2 Laser |
| Classification Name: | Instrument, Surgical, Powered, laser 79-GEX,21 CFR 878-48 |
| Equivalent Device: | LS Family of CO2 Lasers cleared under K040563 |
| Description of the LS Family System: | The LS Family of CO2 lasers are microprocessor-controlled laser systems that incorporate a handpiece todeliver energy to the tissue in a scanned, fractionatedpattern. |
| Intended Use: | The scanning handpiece is intended to be used as anaccessory to the LS Family of CO2 Lasers to deliver thelaser light to the targeted area for skin resurfacing in afractionated manner. |
| Performance Data: | None |
| Results of Clinical Study: | Histology was collected from a small sample of patientsto determine the depth of penetration. |
| Conclusion: | The LS Family of CO2 Lasers with the additionalscanning handpiece is substantially equivalent to thepreviously cleared LS Family of CO2 Lasers. |
{1}------------------------------------------------
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with its wings spread, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular pattern around the eagle. The logo is black and white.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Sandstone Medical Technologies, LLC % Mr. Mark Rohrer Managing Member 105 Citation Court Homewood. Alabama 35209
NOV - 5 2008
Re: K082101
Trade/Device Name: Sandstone Medical Technologies Family of LS CO2 Lasers with Scanning Handpiece 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: September 24, 2008 Received: September 29, 2008
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.
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, 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); good manufacturing practice requirements as set
{2}------------------------------------------------
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.
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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. 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. Millman
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
{3}------------------------------------------------
Indications for Use
KO82101 510(k) Number (if known): K Pending
Device Name:
Sandstone Medical Technologies Family of LS CO2 Lasers with Scanning Handpiece
Skin Resurfacing
Prescription Use XX (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (Part 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)
YlilkRPOde Cir mkm
(Division Sign-Off) Division of General, Restorative, and Neurological Devices
510(k) Number K082101
§ 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.