(253 days)
The Edge 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 Edge CO 2 laser when used in fractionated mode is indicated for ablative skin resurfacing.
The Edge 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 provided 510(k) summary for the Edge CO2 Laser System is for a medical device that uses CO2 laser technology. The device is intended for various dermatological and surgical applications. The summary describes a performance study to demonstrate the device's capabilities, but it does not provide detailed acceptance criteria or results in a format that allows for a direct comparison as requested.
Therefore, I cannot populate the table with specific acceptance criteria and reported performance metrics as this information is not present in the provided text. The summary states: "A study was conducted to show the depth of penetration for each microdot using histology on pigs." This indicates a technical performance test rather than a clinical effectiveness study against predefined criteria.
Here's a breakdown of what can be extracted based on the provided text, and what cannot:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not specified in the provided document. The document mentions a study was conducted but does not detail specific performance thresholds or metrics that the device had to meet. | Not specified in the provided document. The document states "A study was conducted to show the depth of penetration for each microdot using histology on pigs." However, the actual results (e.g., specific depth measurements or a range considered acceptable) are not presented. |
2. Sample size used for the test set and the data provenance:
- Sample Size for Test Set: Not specified. The document only mentions "histology on pigs," implying animal cadaver or live animal testing, but no number of samples (e.g., number of microdots, number of pigs) is given.
- Data Provenance: The study was conducted "on pigs," indicating an animal model. The country of origin of the data is not specified, but the applicant is from Seoul, Korea, so it might have been conducted there. It is a prospective study in the sense that the testing was performed specifically to evaluate this device.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Number of Experts: Not specified.
- Qualifications of Experts: Not specified. It's plausible that a veterinary pathologist or a a medical pathologist familiar with animal histology would have established the ground truth for the histology study, but this is not stated.
4. Adjudication method for the test set:
- Adjudication Method: Not specified. Given this was a histology study to demonstrate depth of penetration, it's likely a single expert (e.g., pathologist) performed the measurements, but a formal adjudication process is not 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:
- MRMC Study: No. This device is a CO2 laser system, not an AI-powered diagnostic or interpretive tool that would involve human readers or AI assistance in interpretation. The performance study was a technical test of laser penetration depth.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Standalone Performance: Not applicable in the context of an AI algorithm. The performance study described is for the physical device itself (laser penetration).
7. The type of ground truth used:
- Type of Ground Truth: Histology measurements. For the "depth of penetration for each microdot," histological examination of the tissue after laser application would provide the direct physical measurement, serving as the ground truth.
8. The sample size for the training set:
- Sample Size for Training Set: Not applicable. This is a physical medical device (CO2 laser), not a machine learning model that requires a training set.
9. How the ground truth for the training set was established:
- Ground Truth for Training Set: Not applicable, as there is no training set for this type of device.
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510(K) Summary Edge CO2 Laser System
NOV 1 Ó 2010
This 510(K) Summary of safety and effectiveness for the Edge 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: | JM System Co., LTD | FDA CDRH DMC |
|---|---|---|
| Address: | 410, Daerung Techno Town 8th481-1, Gasan-dongGeumcheon-guSeoul, Korea 153-775 | SEP 30 2010 |
| Contact Person: | Mr. Su-Gun Lee | Received K31 |
| Telephone:Fax:Email: | 82(02)2163-0158 - phone+82(02)2163-8932 – faxdidvkd@gmail.com | |
| Preparation Date: | February 15, 2010 | |
| Device Trade Name: | Edge CO2 Laser System | |
| Common Name: | CO2 Laser | |
| Classification Name: | Instrument, Surgical, Powered, laser79-ONG, 21 CFR 878-4810 | |
| Legally Marketed PredicateDevice: | Cynosure Affirm CO2 LaserK081424 | |
| Description of the Edge CO2laser | The Edge CO2 laser has a wavelength of 10,600nm. CO2 fractionallaser uses scanning optics to deliver a pattern of thermal energy tothe epidermis and upper dermis. Device accessories include tipattachments. This system consists of main body, color touchscreen, Arm, hand-piece and Foot switch. | |
| Intended use of the Edge CO2laser | The Edge CO 2 laser when used in traditional non-fractionatedscanner mode is indicated for incision, excision, ablation,vaporization, and coagulation of body soft tissues. | |
| The Edge CO 2 laser when used in fractionated mode is indicatedfor ablative skin resurfacing. | ||
| Performance Data: | A study was conducted to show the depth of penetration for eachmicrodot using histology on pigs. | |
| Results of Clinical Study: | None | |
| Conclusion: | The Edge CO2 Laser System is substantially equivalent to thepreviously cleared predicate devices that are currently in | commercial distribution |
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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 circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three curved lines.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
JM System Co., Ltd. % Mr. Su-Gun Lee 410, Daerung Techno Town 8th 481-1, Gasan-dong Geumcheon-gu Seoul, Korea 153-775
NOV 1 0 2010
Re: K100590
Trade/Device Name: Edge 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 Dated: October 18, 2010 Received: November 09, 2010
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 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.
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Page 2 - Mr. Su-Gun Lee
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 (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.
Fiz Dohnson N.N.
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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Page 1 of (1)
Indications for Use
NOV 1 0 2010
510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
Device Name : Edge CO2 Laser System
The Edge 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 Edge 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)
Nulke Syle for mrm
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices
Page 1 of 1
510(k) Number K100590
§ 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.