(97 days)
The equipment is used for human tissue vaporization in dermatology, plastic surgery, and general surgery. The classical scanner is only for the treatment of wrinkles and skin resurfacing.
The subject device, CO2 Laser System (Model: GP900F) mainly consist of console, articulated arm and a foot switch. CO2 laser wavelength is 10600nm, which is used to gasify the skin tissue based on the principle of the theory selective photothermolysis. The water in skin absorbs laser energy and evaporates. By setting up the suitable energy and other parameters on skin tissue, the device can be used for human tissue vaporization and coagulation as well as for the treatment of wrinkles and skin resurfacing.
This document describes the CO2 Laser System (Model: GP900F) and its substantial equivalence to predicate devices, but it does not contain information about specific acceptance criteria, device performance metrics (e.g., accuracy, sensitivity, specificity), or a study designed to prove the device meets such criteria in terms of clinical effectiveness.
The document focuses on demonstrating substantial equivalence to existing legally marketed predicate devices through comparisons of technological characteristics, safety standards, and non-clinical testing. This type of submission (510(k)) generally does not require clinical effectiveness studies in the same way a PMA (Premarket Approval) would.
Therefore, many of the requested details cannot be extracted from the provided text. I will answer the questions based on the information that is available.
1. A table of acceptance criteria and the reported device performance
Based on the provided text, specific acceptance criteria for clinical performance (e.g., accuracy, sensitivity, specificity) and corresponding device performance metrics are not detailed. The acceptance criteria are implicit in the demonstration of substantial equivalence to predicate devices and compliance with safety and performance standards.
The "performance" described relates to adherence to safety standards and the ability to deliver set laser energy parameters within specifications, not clinical outcomes or diagnostic accuracy.
| Category | Acceptance Criteria (Implied by equivalence to predicates and standards) | Reported Device Performance (as demonstrated for SE) |
|---|---|---|
| Functional Equivalence | Similar Indications for Use to Predicate Devices | Equipment used for human tissue vaporization, coagulation in dermatology, plastic surgery, and general surgery. Classical scanner for wrinkles and skin resurfacing. (Same as predicate) |
| Safety | Compliance with IEC 60601-1, IEC 60601-2-22, IEC 60825-1, IEC 60601-1-2 | Passed tests for these standards. |
| Biocompatibility | Compliance with ISO 10993-5, ISO 10993-10 | Passed tests for In Vitro Cytotoxicity, Skin Sensitization, Intracutaneous Reactivity. |
| Software Validation | Compliance with FDA guidance for "moderate" level of concern software | Software functions as specified in requirement specifications. |
| Bench Performance | Deliver set laser energy parameters within specifications | Device delivers set laser energy parameters within specifications. |
| Technological Characteristics | Similar key specifications (Output Power, Laser Wavelength, etc.) to Predicate Devices | Device matches or is similar in key specifications to predicate devices (e.g., 30W output, 10600nm wavelength, <5mW aiming beam power at 650nm). |
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
Not applicable/Not provided. This document details a 510(k) submission, which typically relies on non-clinical testing and comparison to predicate devices, rather than clinical studies with test sets in the context of diagnostic or treatment accuracy. The "test set" here refers to the units of the device itself and materials used for engineering and biocompatibility tests.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)
Not applicable/Not provided. Ground truth, in the context of clinical outcomes or diagnostic accuracy, is not discussed. The "truth" for this submission is compliance with established device safety and performance standards and technological equivalence to predicate devices. Experts involved would be engineers, physicists, and toxicologists related to the conducted tests.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable/Not provided. This refers to methods for resolving discrepancies in clinical assessments, which is not relevant to this type of device submission presented here.
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/Not provided. This device is a CO2 Laser System, a surgical instrument. It is not an AI-assisted diagnostic or interpretation device that would typically involve human "readers" or MRMC studies.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable/Not provided. The CO2 Laser System is a surgical instrument operated by a human, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for this 510(k) submission is primarily established through:
- Compliance with recognized international standards: IEC 60601-1, IEC 60601-2-22, IEC 60825-1, IEC 60601-1-2, ISO 10993-5, ISO 10993-10, and FDA guidance for software.
- Bench performance testing: Demonstrating that the device physically delivers its intended laser energy parameters as specified.
- Comparison to predicate devices: Establishing that the technological characteristics and indications for use are substantially equivalent to devices already cleared by the FDA.
8. The sample size for the training set
Not applicable/Not provided. There is no mention of a "training set" in the context of machine learning or AI models, as this is a physical medical device. If "training set" refers to manufacturing processes or quality control, that information is not detailed here.
9. How the ground truth for the training set was established
Not applicable/Not provided. As there is no "training set" for an AI or machine learning model, the establishment of ground truth in that context is not relevant.
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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: a symbol on the left and the FDA name and title on the right. The symbol on the left is a stylized representation of a human figure, while the text on the right reads "FDA U.S. FOOD & DRUG ADMINISTRATION" in blue letters.
September 12, 2019
Feiying Drug & Medical Consulting Technical Service Group Becky Chen Registered Engineer B-3F 3005, Bldg. 1, Southward Ruifeng Business Center, No. 22 Guimiao Rd. Shenzhen, CN 518000 Guangdong
Re: K191518
Trade/Device Name: CO2 Laser System (Model: GP900F) 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: GEX Dated: August 15, 2019 Received: August 19, 2019
Dear Becky Chen:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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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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 of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
Purva Pandya Acting Assistant Director DHT4A: Division of General Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K191518
Device Name CO2 Laser System (Model: GP900F)
Indications for Use (Describe)
The equipment is used for human tissue vaporization in dermatology, plastic surgery, and general surgery. The classical scanner is only for the treatment of wrinkles and skin resurfacing.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ------------------------------------------------- | -- |
X Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
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510 (k) Summary
This "510(k) Summary" of 510(k) safety and effectiveness information is submitted in accordance with requirements of Title 21, CFR Section 807.92.
(1) Applicant information:
| 510(k) owner's name: | SHENZHEN GSD TECH CO., LTD |
|---|---|
| Address: | BUILDING A JUNSD HI-TECH PARK, WEST OFBAO'AN RD. WATCH & CLOCK BASE, GUANGMINGDISTRICT, SHENZHEN, GUANGDONG, CHINA |
| Contact person: | Jiancheng zhang |
| Phone number: | +86-13632740353 |
| Fax number: | +86-0755-29109786 |
| Email: | 535140627@qq.com |
| Date of summary prepared: | 2019-09-11 |
(2) Proprietary name of the device
| Trade name/model: | CO2 Laser System (Model: GP900F) |
|---|---|
| Common name: | Laser Surgical Instrument for Use In General And PlasticSurgery And In Dermatology |
| Regulation number: | 21CFR 878.4810 |
| Product code: | GEX |
| Review panel: | General & Plastic Surgery |
| Regulation class: | II |
(3) Predicate devices
| Primary Predicate | Reference Predicate | |
|---|---|---|
| Sponsor | Beijing Sincoheren Science andTechnology Development Co., Ltd. | Jeisys Medical Inc. |
| DeviceName | CO2 Laser Therapy System | EdgeOne CO2 Laser |
| 510(k)Number | K162398 | K162169 |
| ProductCode | GEX | GEX, ONG |
| RegulationNumber | 21 CFR 878.4810 | 21 CFR 878.4810 |
| Regulation | II | II |
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Class
(4) Description/ Design of device:
The subject device, CO2 Laser System (Model: GP900F) mainly consist of console, articulated arm and a foot switch. CO2 laser wavelength is 10600nm, which is used to gasify the skin tissue based on the principle of the theory selective photothermolysis. The water in skin absorbs laser energy and evaporates. By setting up the suitable energy and other parameters on skin tissue, the device can be used for human tissue vaporization and coagulation as well as for the treatment of wrinkles and skin resurfacing.
(5) Intended use / Indications for use:
The equipment is used for human tissue vaporization, coagulation in dermatology, plastic surgery, and general surgery. The classical scanner is only for the treatment of wrinkles and skin resurfacing.
(6) Materials
| Component name | Material ofComponent | Body ContactCategory | Contact Duration |
|---|---|---|---|
| Treatment handpiece | Stainless steel 316L | Surface skin contact | Less than 24 hours |
The treatment hand piece used in the CO2 Laser Systems has passed the Biocompatibility test. For details, please refer to "Biocompatibility Discussion".
(7) Technological characteristics and substantial equivalence:
| Item | Proposed device | Primary Predicate | ReferencePredicate | Remark |
|---|---|---|---|---|
| Trade name | CO2 Laser System(Model: GP900F) | CO2 Laser TherapySystem | EdgeOne CO2Laser | / |
| Manufacturer | SHENZHEN GSDCO., LTD | Beijing SincoherenScience andTechnologyDevelopment Co.,Ltd. | JEISYSMEDICAL INC. | / |
| 510 (k)number | / | K162398 | K162169 | / |
| Regulationnumber | 21 CFR 878.4810 | 21 CFR 878.4810 | 21 CFR 878.4810 | Same |
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| Regulationdescription | Laser surgicalinstrument for use ingeneral and plasticsurgery and indermatology. | Laser surgicalinstrument for use ingeneral and plasticsurgery and indermatology. | Laser surgicalinstrument for usein general andplastic surgery andin dermatology. | Same |
|---|---|---|---|---|
| Productcode | GEX | GEX | GEX | Same |
| Class | II | II | II | Same |
| Indicationsfor use/Intendeduse | The equipment isused for humantissue vaporization,coagulation indermatology, plasticsurgery, and generalsurgery. Theclassical scanner isonly for thetreatment ofwrinkles and skinresurfacing. | The equipment isused for humantissue vaporization,coagulation indermatology, plasticsurgery, and generalsurgery. Thefractional scanner isonly for thetreatment ofwrinkles and skinresurfacing. | It is indicated forincision, excision,ablation,vaporization andcoagulation ofbody soft tissues inmedical specialtiesincluding aesthetic(dermatology andplastic surgery),podiatry,otolaryngology(ENT), gynaecology,neurosurgery,orthopaedics,general andthoracic surgery(including openand endoscopic),dental and oralsurgery andgenitourinarysurgery. The usewith the scanningunit is indicated forablative skinresurfacing. | Same |
| Location foruse | Prescription Use | Prescription Use | Prescription Use | Same |
| Basic unit specifications | ||||
| Powersupply | 110-240VAC,50-60Hz | 110-240VAC,50-60Hz | 230V~, 50/60Hz | Same |
| Dimensions | 480mm380mm1053mm | 460mm×430mm×1170mm | NA | DifferentNote 1 |
| Weight | 46kg | 65kg | NA | Different |
| Note 1 | ||||
| Majorcomponents | Console, articulatedarm and a footswitch. | Console, articulatedarm and a footswitch. | Main console unit,articulated arm anda foot switch. | Same |
| Compliancewithvoluntarystandards | IEC 60601-1IEC 60601-2-22IEC 60825-1IEC 60601-1-2 | IEC 60601-1IEC 60825-1IEC 60601-1-2 | IEC 60601-1IEC 60601-2-22IEC 60601-1-2 | Same |
| Performance specification | ||||
| OutputPower(Maximum) | 30W | 30W | 30W | Same |
| Work Mode | Classical mode,Surgical mode(Single Pulse,Continuous,Muti-Pulse) | Scan (Single Pulse,Continuous,Muti-Pulse) | Fractional mode,normal mode (CW,Pulse, Single Pulse,Repeat, Grouppulse, Ultra) | Same |
| LaserMedium/Energy Source | CO2 | CO2 | CO2 | Same |
| CO2 LaserWavelength | 10600nm | 10600nm | 10600nm | Same |
| AimingBeamWavelength | Red diode laser650nm±10nm | Red diode laser 635nm | Red diode laser655 +/- 10nm | SimilarNote 2 |
| AimingBeamPower | < 5mW | < 5mW | NA | Same |
| Spot Size(Classical) | 0.5mm | 0.5mm | 120µm, 350µm,800µm | Same |
| ClassicalPulseEnergy | 0.1mJ~300mJ | 1mj-100mj isoptional for each dot | 1-300mJ | Same |
| PulseDuration | Classical mode:0.1ms | NA | 1-1000ms | Same |
| Repetitionrate | 10-500Hz | NA | 10-500Hz | Same |
| Cooling | Air cooling | Air cooling | Water cooling | Same |
| ControlSystem | Touch screen,footswitch | Touch screen,footswitch | Touch screen,footswitch | Same |
| Laser | Footswitch | Footswitch | Footswitch | Same |
| Operation | ||||
| PatientContactSites | Skin | Skin | Skin | Same |
| Biocompatibility | Passed the test asper ISO 10993-5and ISO 10993-10 | Passed the test asper ISO 10993-5and ISO 10993-10 | Passed the test asper ISO 10993-5and ISO 10993-10 | Same |
| ElectricalSafety | Passed the test asper IEC 60601-1and IEC 60601-2-22 | Passed the test asper IEC 60601-1 | Passed the test asper IEC 60601-1and IEC60601-2-22 | Same |
| EMC | Passed the test asper IEC 60601-1-2 | Passed the test asper IEC 60601-1-2 | Passed the test asper IEC 60601-1-2 | Same |
| Performance | Passed the test asper IEC 60601-2-22and IEC 60825-1 | Passed the test asper IEC60825-1 | Passed the test asper IEC60601-2-22 | Same |
| Compliancewith 21CFR898 | Yes | Yes | Yes | Same |
| Sterility | Non-sterile | Non-sterile | Non-sterile | Same |
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Note 1:
Although the appearance, weight and dimension are different between the target device, predicate devices, these differences are insignificant and do not adversely affect safety and effectiveness of the subject device compared to the predicate.
Note 2:
Similar aiming beam wavelength between the target device and predicate devices. The difference does not raise different questions of safety and effectiveness.
Conclusion:
CO2 Laser System (Model: GP900F) is substantial equivalent to the predicate device.
(8) Non-clinical studies and tests performed:
Non-clinical testing is conducted to verify that the CO2 Laser System meets all design specifications which supports the conclusion that it's Substantially Equivalent (SE) to the predicate device. The testing results demonstrate that the Proposed device complies with the following standards:
- A IEC60601-1, Medical electrical equipment -- Part 1: General requirements for basic safety and essential performance
- A IEC 60601-2-22, Medical electrical equipment-Part2: Particular requirements for basic safety and essential performance of surgical, cosmetic, therapeutic and diagnostic laser
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equipment
-
IEC 60825-1. Safety of Laser Products- Part 1: Equipment classification and requirements
-
IEC60601-1-2, Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic disturbances - Requirements and tests
The body-contacting components of this device are the treatment head. The biocompatibility evaluation for the CO2 Laser Systems was conducted in accordance with the guidance "Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process" as recognized by FDA. The treatment head is considered skin and subcutaneous tissue contacting for a duration of less than 24 hours. The biocompatible testing included In Vitro Cytotoxicity, Skin Sensitization and Intracutaneous Reactivity was conducted in compliance with:
- A ISO 10993-5, Biological Evaluation Of Medical Devices -- Part 5: Tests For In Vitro Cytotoxicity
- A ISO 10993-10, Biological Evaluation Of Medical Devices - Part 10: Tests For Irritation And Skin Sensitization
We have also conducted:
- Software verification and validation test according to the requirements of the FDA A "Guidance for Pre Market Submissions and for Software Contained in Medical Devices". The software for this device was considered as a "moderate" level of concern. Software validation demonstrated that the software functions as specified in the software requirement specifications.
- Bench performance testing to show that the device delivers set laser energy A parameters within specifications.
(9) Conclusion
Based on the above analysis and tests performed. it can be concluded that the subject device CO2 Laser System (Model: GP900F) is Substantially Equivalent (SE) to the predicate devices.
§ 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.