(245 days)
The Medical Non-ablative Fractional Laser Systems (Model: WFB-01) is intended for use in dermatological procedures requiring fractional skin resurfacing and coagulation of soft tissue.
The Medical Non-ablative Fractional Laser Systems (Model: WFB-01) is intended for use in dermatological procedures requiring skin resurfacing and coagulation of soft tissue.
The Medical Non-ablative Fractional Laser Systems (Model: WFB-01) includes three main parts, Main Console, Connector and Scan Handpiece.
The main console is used for system control, such as control of user interface, power on/off and other functions, and also used as holder for other components.
The Connector is used to connect with accessories or power supplier, such as foot switch, pipeline holder, cold air device etc.
The Scan Handpiece is used to provide laser emission and graphic scanning functions. It provides three scan heads (AccuTip, EffiTip, GrowTip) for treatment areas.
This document is a 510(k) Summary for a medical device called "Medical Non-Ablative Fractional Laser Systems (Model: WFB-01)" by Wingderm Electro-Optics Ltd. It states that no clinical tests were conducted. Therefore, there is no information available in the provided text regarding acceptance criteria, device performance, sample sizes, ground truth, expert qualifications, or MRMC studies that would typically be associated with a clinical study.
The submission is based on substantial equivalence to a predicate device (Lumenis, Ltd.'s M22 And Resurfx Systems, K170060) through non-clinical testing.
Here's a breakdown of the information that is available, specifically highlighting the absence of clinical study data:
1. A table of acceptance criteria and the reported device performance
Since no clinical study was performed, there's no table of clinical acceptance criteria or reported clinical device performance based on human subjects. The table provided (Table 2 Performance Comparison) focuses on technical specifications and shows the proposed device's specifications are "SAME" or "Analysis" (meaning there's a difference but it's deemed not to affect safety/effectiveness) compared to the predicate device.
| ITEM | Proposed Device | Predicate DeviceK170060 | Remark |
|---|---|---|---|
| Wavelengths | 1550 nm | 1565 nm | SAME |
| Fluence | Up to 70 mJ per Micro-beam | Up to 70 mJ per Micro-beam | SAME |
| Laser Power | 15 W | 15 W | SAME |
| Dot Density(Dot/cm²) | 500 | Up to 500 | SAME |
| Laser BeamDiameter | 110 um | 110 um | SAME |
| Inter-beamspacing | 0.4 mm - 1.0 mm | 0.4 mm - 1.0 mm | SAME |
| Beam diametervariability | Fixed | Fixed | SAME |
| Pulse Duration | 10 ms | 10 ms | SAME |
| Type of laser | Er:Glass | Er:Glass | SAME |
| Tip treatmentArea | AccuTip: 10mmX10mm,EffiTip: 20mmX20mmGrowTip: 10mmX20mm | 18mm SapphireCool Tip18mm Precision Tip | Analysis |
| Scanning shapes | Rectangle, Hexagon, Ellipse, Triangle,Circle | Line, square, rectangle, circle, donut,hexagon, vertical line, and vertical rectangle | Analysis |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
Not applicable, as no clinical study was conducted.
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, as no clinical study was conducted with a test set requiring expert ground truth.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable, as no clinical study was conducted.
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. The device is a laser system, not an AI-assisted diagnostic tool. No MRMC study was mentioned.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. The device is a laser system, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable, as no clinical study was conducted. The "ground truth" for demonstrating substantial equivalence relied on non-clinical engineering and performance testing against recognized standards and comparison to a predicate device's specifications.
8. The sample size for the training set
Not applicable, as no clinical study was conducted or AI algorithm trained.
9. How the ground truth for the training set was established
Not applicable, as no clinical study was conducted or AI algorithm trained.
Summary based on the provided document:
The device, "Medical Non-Ablative Fractional Laser Systems (Model: WFB-01)," obtained 510(k) clearance by demonstrating substantial equivalence to a predicate device based on non-clinical testing. This included adherence to international standards for medical electrical equipment safety, electromagnetic compatibility, laser safety, and biocompatibility, as well as performance testing for energy output accuracy. No clinical studies were performed, and therefore, no clinical performance data, patient sample sizes, expert-established ground truth, or MRMC studies are discussed in this document.
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Wingderm Electro-Optics Ltd. % Ray Wang Beijing Believe-Med Technology Service Co., Ltd. Rm. 912, Building #15, XiYueHui, No.5, YiHe North Rd., Fangshan District Beijing, 102401 CN
Re: K192350
Trade/Device Name: Medical Non-Ablative Fractional Laser Systems 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: August 21, 2019 Received: August 29, 2019
Dear Ray Wang:
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.
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
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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,
Colin Kejing Chen Acting Assistant Director DHT4A: Division of General Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) K192350
Device Name
Medical Non-ablative Fractional Laser Systems (Model: WFB-01)
Indications for Use (Describe)
The Medical Non-ablative Fractional Laser Systems (Model: WFB-01) is intended for use in dermatological procedures requiring fractional skin resurfacing and coagulation of soft tissue.
| Type of Use (Select one or both, as applicable) | Prescription Use (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 801 Subpart C) |
|---|---|
| ------------------------------------------------- | ----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- |
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Tab #3 510(k) Summary
This 510(k) Summary of 510(k) safety and effectiveness information is being submitted in accordance with requirements of SMDA 1990 and Title 21, CFR Section 807.92.
The assigned 510(k) Number: K192350
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- Date of Preparation
04/26/2020
- Date of Preparation
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Sponsor 2.
Wingderm Electro-Optics Ltd.
Room 312, Building D-3, Dongsheng Science Park, No.66 Xixiaokou Road, Haidian District, 100192 Beijing, China Contact Person: Juan Zhou Position: Quality Manager Tel: +86- 18513353536 Email: zhoujuan@wingderm.com
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- Submission Correspondent
Mr. Ray Wang
- Submission Correspondent
Beijing Believe-Med Technology Service Co., Ltd.
Rm.912, Building #15, XiYueHui, No.5, YiHe North Rd., FangShan District, BeiJing, China 102401 Tel: +86-18910677558 Fax: +86-10-56335780 Email: ray.wang@believe-med.com
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- Identification of Proposed Device
Trade Name: Medical Non-ablative Fractional Laser Systems Common Name: Medical Non-ablative Fractional Laser Systems Model(s): WFB-01
- Identification of Proposed Device
Regulatory Information:
Classification Name: Powered laser surgical instrument with microbeam\fractional output Classification: 2; Product Code: ONG; Regulation Number: 21 CFR 878.4810; Review Panel: General & Plastic Surgery;
Intended Use Statement:
The Medical Non-ablative Fractional Laser Systems (Model: WFB-01) is intended for use in dermatological procedures requiring fractional skin resurfacing and coagulation of soft tissue.
-
- Device Description
The Medical Non-ablative Fractional Laser Systems (Model: WFB-01) is intended for use in dermatological procedures requiring skin resurfacing and coagulation of soft tissue.
- Device Description
The Medical Non-ablative Fractional Laser Systems (Model: WFB-01) includes three main parts, Main Console, Connector and Scan Handpiece.
The main console is used for system control, such as control of user interface, power on/off and other functions, and also used as holder for other components.
The Connector is used to connect with accessories or power supplier, such as foot switch, pipeline holder, cold air device etc.
The Scan Handpiece is used to provide laser emission and graphic scanning functions. It provides three scan heads (AccuTip, EffiTip, GrowTip) for treatment areas.
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- Identification of Predicate Device
Predicate Device: 510(k) Number: K170060 Product Name: M22 And Resurfx Systems Manufacturer: Lumenis, Ltd.
- Identification of Predicate Device
-
- Non-Clinical Test Conclusion
Non clinical tests were conducted to verify that the proposed device met all design specifications as was Substantially Equivalent (SE) to the predicate device. The test results demonstrated that the proposed device complies with the following standards:
- Non-Clinical Test Conclusion
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AAMI/ANSI/ES 60601-1:2012 Medical Electrical Equipment - Part 1: General Requirements For Basic Safety And Essential Performance;
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IEC 60601-2-22 Edition 3.1 2012-10, Medical Electrical Equipment - Part 2-22: Particular Requirements For Basic Safety And Essential Performance Of Surgical, Cosmetic, Therapeutic And Diagnostic Laser Equipment.
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IEC 60825-1:2014, Safety of laser products - Part 1: Equipment classification and requirements.
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IEC 60601-1-2:2014 , Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances -Requirements and tests
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ISO 10993-5 Third Edition 2009-06-01, Biological Evaluation Of Medical Devices - Part 5: Tests For In Vitro Cytotoxicity.
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ISO 10993-10 Third Edition 2010-08-01, Biological Evaluation Of Medical Devices - Part 10: Tests For Irritation And Skin Sensitization.
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Performance Testing for Energy Output Accuracy.
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- Clinical Test Conclusion
No Clinical Test conducted.
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Substantially Equivalent (SE) Comparison 9.
| ITEM | Proposed Device | Predicate DeviceK170060 | Remark |
|---|---|---|---|
| Product Code | ONG | GEX, ONF, ONG | SAME |
| Regulation No. | 21 CFR 878.4810 | 21 CFR 878.4810 | SAME |
| Class | 2 | 2 | SAME |
| Intended Use | The Medical Non-ablative FractionalLaser Systems (Model: WFB-01) isintended for use in dermatologicalprocedures requiring fractional skinresurfacing and coagulation of soft tissue. | ResurFX module and handpiece, withwavelength of 1565 nm, is indicated for Usein dermatological procedures requiringfractional skin resurfacing and coagulationof soft tissue | SAME |
| Prescription/OTC | Prescription Use | Prescription Use | SAME |
Table 1 General Comparison
Table 2 Performance Comparison
| ITEM | Proposed Device | Predicate DeviceK170060 | Remark |
|---|---|---|---|
| Wavelengths | 1550 nm | 1565 nm | SAME |
| Fluence | Up to 70 mJ per Micro-beam | Up to 70 mJ per Micro-beam | SAME |
| Laser Power | 15 W | 15 W | SAME |
| Dot Density(Dot/cm²) | 500 | Up to 500 | SAME |
| Laser BeamDiameter | 110 um | 110 um | SAME |
| Inter-beamspacing | 0.4 mm - 1.0 mm | 0.4 mm - 1.0 mm | SAME |
| Beam diametervariability | Fixed | Fixed | SAME |
| Pulse Duration | 10 ms | 10 ms | SAME |
| Type of laser | Er:Glass | Er:Glass | SAME |
| Tip treatmentArea | AccuTip: 10mmX10mm,EffiTip: 20mmX20mmGrowTip: 10mmX20mm | 18mm SapphireCool Tip18mm Precision Tip | Analysis |
| Scanning shapes | Rectangle, Hexagon, Ellipse, Triangle,Circle | Line, square, rectangle, circle, donut,hexagon, vertical line, and vertical rectangle | Analysis |
Difference Analysis:
The design and technological characteristics of the subject device is basically similar to the predicate device chosen. There are minor differences between the devices including Treatment Area and Scanning shapes. These two specifications are only for different area but not affects the treatment power (fluence). So, there is no deleterious effect on safety and effectiveness due to the differences, and these minor
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differences do not influence the intended use function and use of the device. Moreover, the non-clinical tests and the predicate comparisons demonstrate that these differences in their technological characteristics do not raise any questions as to the safety and effectiveness. Therefore, the subject device is substantially equivalent to the Predicate device.
| ITEM | Proposed Device | Predicate DeviceK170060 | Remark |
|---|---|---|---|
| Safety | Comply with IEC 60601-1 | Comply with IEC 60601-1 | SAME |
| EMC | Comply with IEC 60601-1-2 | Comply with IEC 60601-1-2 | SAME |
| Performance Test | Comply with IEC 60601-2-22 and IEC60825-1 | Comply with IEC 60601-2-22 and IEC60825-1 | SAME |
| Biocompatibility | Comply with ISO 10993-1 | Comply with ISO 10993-1 | SAME |
| Label andLabeling | Conforms to FDA RegulatoryRequirements | Conforms to FDA RegulatoryRequirements | SAME |
Table 3 Safety Comparison
10. Substantially Equivalent (SE) Conclusion
Based on the comparison and analysis above, the proposed device is determined to be Substantially Equivalent (SE) to the predicate device.
§ 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.