(75 days)
The Multi-modality workstation (inclusive of the handpiece used to deliver pulsed-light energy) is indicated for use in surgical and aesthetic applications in permanent hair removal, reduction of benign pigmented lesions and benign vascular lesions.
Permanent hair reduction is defined as the long-term, stable reduction in the number of hairs regrowing when measured at 6, 9, and 12 months after the completion of a treatment regimen.
The Multi-modality workstation is an intense pulsed light system which delivers intense pulsed light at a wavelength ranging from 520mm. Intense Pulsed Light (IPL) systems work on the principles of selective thermolysis. That is, causing thermal damage to target chromophores by using light of appropriate wavelength in pulses that exceeds the chromophores' thermal relaxation time but sparing normal skin by limiting the pulse width below the thermal relaxation time for skin.
IPL Systems are different from lasers in that they deliver many wavelengths in each pulse of light instead of just one wavelength. Generally, IPL enhances penetration without using excessive energy levels and enables targeting of specific chromophores.
Based on this, the Multi-modality workstation (inclusive of the handpiece used to deliver pulsed-light energy) is indicated for use in surgical and aesthetic applications in permanent hair removal, and reduction of benign pigmented lesions and benign vascular lesions.
This document is a 510(k) Premarket Notification summary for the "Multi-modality workstation, Model: AAD Dual Light." It demonstrates Substantial Equivalence (SE) to a predicate device, rather than providing a study that meets specific acceptance criteria for a new clinical claim.
Therefore, many of the requested details regarding acceptance criteria and performance studies in the context of clinical claims (e.g., sample size, expert ground truth, MRMC studies) are not applicable (N/A) to this type of submission. This 510(k) primarily relies on non-clinical testing and comparative analysis to establish substantial equivalence.
Here's a breakdown of the requested information based on the provided document:
1. A table of acceptance criteria and the reported device performance
The concept of "acceptance criteria" in this 510(k) is framed around demonstrating substantial equivalence to a predicate device, specifically by meeting certain non-clinical performance and safety standards, and having comparable technological characteristics and intended use. There isn't a table of specific clinical performance acceptance criteria and reported clinical device performance because no clinical study was performed.
Instead, the document presents a comparison table with the predicate device (Table 9-2 Performance Comparison and Table 9-3 Setting Comparison of Specified Indication for Use), where "acceptance" means the proposed device's characteristics are either the same or have differences that are argued to have no negative effect on effectiveness and safety, supported by non-clinical bench tests.
Here's a summary of the comparative performance aspects:
| Aspect | Acceptance Criteria (Demonstrated by Substantial Equivalence Basis) | Reported Device Performance (vs. Predicate) |
|---|---|---|
| Product Code | ONF | ONF (SAME) |
| Regulation No. | 21 CFR 878.4810 | 21 CFR 878.4810 (SAME) |
| Class | II | II (SAME) |
| Intended Use | Consistent with predicate: Permanent hair removal, reduction of benign pigmented lesions and benign vascular lesions. | SAME as predicate. |
| Light Source | Intense Pulsed Light | Intense pulsed light (SAME) |
| Wavelength | Range closed to predicate, slight differences not negatively affecting safety/efficacy, supported by bench tests. | Different ranges for general (520-650; 800~1200; 540-800; 640-1200 vs. 480-1200; 590-1200; 640-1200) and specific indications, but considered "very closed" and differences analyzed to have no negative effect. |
| Delivery System | Sapphire | Sapphire (SAME) |
| Energy Density | Within range of predicate, slight differences not negatively affecting safety/efficacy, supported by bench tests. | 1-50 J/cm2 (SAME as predicate for general, but specific indication ranges varied slightly, e.g., 5-40 for hair removal vs. 10-44 for predicate. "Analysis 2" states differences do not result in negative safety/efficacy). |
| Pulse Width | Within range of predicate, slight differences not negatively affecting safety/efficacy, supported by bench tests. | 1-25 ms (SAME as predicate for general, but specific indication ranges varied slightly, e.g., 1-25 for hair removal vs. 3-14 for predicate. "Analysis 3" states differences do not result in negative safety/efficacy). |
| Max. Power | Conforms to IEC 60601-1 and IEC 60601-1-2 regarding device safety and electromagnetic compatibility despite differences with predicate. | 3500VA (vs. 2200W for predicate). "Analysis 5" justifies higher power by conformance to safety standards. |
| Spot Size | Differences not considered to produce a negative effect on safety, supported by bench tests. | Small: 40x12mm, Large: 46x16mm, Ex-Large: 60x20mm (vs. 12x30mm for predicate). "Analysis 4" states differences in spot sizes are not considered to produce a negative effect on safety. |
| Electrical Safety | Compliance with IEC 60601-1 | Tested to comply with IEC 60601-1 (SE) |
| EMC | Compliance with IEC 60601-1-2 | Tested to comply with IEC 60601-1-2 (SE) |
| Biocompatibility | No toxicity (ISO 10993-5), No irritation (ISO 10993-10), No sensitization (ISO 10993-10) | Cytotoxicity: No toxicity (SE) Irritation: Applied sample did not induce irritation to skin (SE) Sensitization: Test article showed no significant evidence of causing skin sensitization in guinea pig (SE) |
| Power Supply | Conforms to IEC 60601-1 and IEC 60601-1-2 regarding device safety and electromagnetic compatibility despite differences with predicate. | 110V, 60Hz or 230V, 50Hz (vs. 110V 50Hz for predicate). "Analysis 6" justifies differences by conformance to safety standards. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size for Test Set: N/A. No clinical test set data was used because no clinical study was included in the submission. The "test set" was comprised of the physical device itself undergoing non-clinical bench testing.
- Data Provenance: N/A. The data for this submission primarily comes from the manufacturer's internal non-clinical bench testing and adherence to international electrical and biocompatibility standards.
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)
- Number of Experts: N/A. Since no clinical study was performed, there was no need for experts to establish ground truth for clinical cases.
- Qualifications of Experts: N/A.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Adjudication Method: N/A. No clinical study, thus no adjudication of clinical outcomes. The "adjudication" for non-clinical tests would be the pass/fail criteria of the specified international standards (e.g., IEC, ISO).
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: N/A. No clinical study. The device is a light-based system for aesthetic and surgical applications, not an AI-assisted diagnostic device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Standalone Performance: N/A. This device is an intense pulsed light system, not an algorithm. Its performance is inherent in its physical parameters and how it operates, validated by non-clinical bench tests. It requires human operation.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Ground Truth: For non-clinical testing, the "ground truth" refers to the established requirements and specifications of the referenced international standards (e.g., IEC, ISO). For example, for biocompatibility, "no toxicity" or "no irritation" based on ISO 10993 series are the established ground truths/acceptance criteria for the material. For electrical safety, compliance with IEC 60601-1 is the ground truth. There is no clinical ground truth relevant to this 510(k).
8. The sample size for the training set
- Training Set Sample Size: N/A. No clinical training data was used because this is a physical device submission demonstrating substantial equivalence through non-clinical means, not a machine learning/AI device.
9. How the ground truth for the training set was established
- Ground Truth for Training Set: N/A. See point 8.
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November 27, 2019
Beijing Superlaser Technology Co., Ltd. % Ray Wang General Manager Beijing Believe-Med Technology Service Co., Ltd. Rm.912, Building #15, XiYueHui, No.5, YiHe North Rd., FangShan District BeiJing, 102401 CN
Re: K192519
Trade/Device Name: Multi-modality workstation, Model: AAD Dual Light 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: ONF Dated: September 9, 2019 Received: September 13, 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
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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 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 Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K192519
Device Name
Multi-modality workstation, Model: AAD Dual Light
Type of Use (Select one or both, as applicable)
Indications for Use (Describe)
The Multi-modality workstation (inclusive of the handpiece used to deliver pulsed-light energy) is indicated for use in surgical and aesthetic applications in permanent hair removal, reduction of benign pigmented lesions and benign vascular lesions.
Permanent hair reduction is defined as the long-term, stable reduction in the number of hairs regrowing when measured at 6, 9, and 12 months after the completion of a treatment regimen.
| ☑ 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 being submitted in accordance with requirements of SMDA 1990 and Title 21, CFR Section 807.92.
The assigned 510(k) Number: K192519
-
- Date of Preparation: 11/27/2019
-
- Sponsor Identification
Beijing Superlaser Technology Co., Ltd.
No.2 Zhongfu Street, Economic and Technological Industrial Zone, Xihongmen Town, Daxing District, Beijing, 100076, China
Contact Person: Shi Shuang Position: Registration Specialist Tel: +86-10-81284899 ext. 806 Fax: +86-10-81284899 Email: 672257488@qq.com
-
- Designated Submission Correspondent
Mr. Ray Wang
- Designated 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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4. Identification of Proposed Device
Trade Name: Multi-modality workstation
Common Name: Powered Light Based Non-Laser Surgical Instrument With Thermal Effect Model(s): AAD Dual Light
Regulatory Information:
Classification Name: Laser surgical instrument for use in general and plastic surgery and in dermatology; Classification: II;
Product Code: ONF;
Regulation Number: 21 CFR 878.4810;
Review Panel: General & Plastic Surgery;
Indication For Use Statement:
The Multi-modality workstation (inclusive of the handpiece used to deliver pulsed-light energy) is indicated for use in surgical and aesthetic applications in permanent hair removal, reduction of benign pigmented lesions and benign vascular lesions.
Permanent hair reduction is defined as the long-term, stable reduction in the number of hairs regrowing when measured at 6, 9, and 12 months after the completion of a treatment regimen.
Device Description:
The Multi-modality workstation is an intense pulsed light system which delivers intense pulsed light at a wavelength ranging from 520mm. Intense Pulsed Light (IPL) systems work on the principles of selective thermolysis. That is, causing thermal damage to target chromophores by using light of appropriate wavelength in pulses that exceeds the chromophores' thermal relaxation time but sparing normal skin by limiting the pulse width below the thermal relaxation time for skin.
IPL Systems are different from lasers in that they deliver many wavelengths in each pulse of light instead of just one wavelength. Generally, IPL enhances penetration without using excessive energy levels and enables targeting of specific chromophores.
Based on this, the Multi-modality workstation (inclusive of the handpiece used to deliver pulsed-light energy) is indicated for use in surgical and aesthetic applications in permanent hair removal, and reduction of benign pigmented lesions and benign vascular lesions.
5. Identification of Predicate Device(s)
510(k) Number: K161286 Predicate Device Name: IPL Therapy Machine Manufacturer: Beijing ADSS Development Co., Ltd
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6. Non-Clinical Test Conclusion
Non-clinical tests were conducted to verify that the proposed device met all design specifications to support that it is Substantially Equivalent (SE) to the predicate device. The test results demonstrated that the proposed device conforms to the following standards:
a) IEC60601-1-2 Edition 4.0 2014-02 Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests.
b) AAMI/ANSI/ES 60601-1:2005/A1:2012, Medical equipment - Part 1: General requirements for basic safety and essential performance
c) IEC60601-2-57:2011, Medical electrical equipment -- Part 2-57: Particular requirements for the basic safety and essential performance of non-laser light source equipment intended for therapeutic, diagnostic, monitoring and cosmetic/aesthetic use
d) IEC 62471 First edition 2006-07, Photobiological safety of lamps and lamp systems
e) ISO 10993-5:2009, Biological Evaluation of Medical Device, Part 5-Tests for Vitro cytotoxicity. f) ISO 10993-10:2010 Standard, Biological Evaluation of Medical Device, Part 10-Test for irritation and delay-type hypersensitivity.
- Clinical Test Conclusion 7.
No clinical study is included in this submission.
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Substantially Equivalent (SE) Comparison 8.
| ITEM | Proposed Device | Predicate DeviceIPL Therapy Machine VE2000(K161286) | Remark |
|---|---|---|---|
| Product Code | ONF | ONF | SAME |
| RegulationNo. | 21 CFR 878.4810 | 21 CFR 878.4810 | SAME |
| Class | II | II | SAME |
| Intended Use | The Multi-modalityworkstation (inclusive of thehandpiece used to deliverpulsed-light energy) is indicated foruse in surgical and aestheticapplications in permanent hairremoval, reduction of benignpigmented lesions and benignvascular lesions.Permanent hair reduction is definedas the long-term, stable reduction inthe number of hairs regrowing whenmeasured at 6, 9, and 12 monthsafter the completion of a treatmentregimen. | The VE2000 device is indicatedfor use in surgical, aestheticapplications in permanent hairreduction, reduction of benignpigmented lesions and benignvascular lesions.Permanent hair reduction isdefined as the long-term, stablereduction in the number of hairsregrowing when measured at 6, 9,and 12 months after thecompletion of a treatmentregimen. | SAME |
| Table 9-1 General Comparison |
|---|
| ------------------------------ |
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| ITEM | Proposed Device | Predicate DeviceIPL Therapy Machine VE2000Systems(K161286) | Remark |
|---|---|---|---|
| Light source | Intense pulsed light | Intense pulsed light | SAME |
| Wavelength | 520-650;800~1200;540-800;640-1200; | 480nm-1200nm590nm-1200nm640nm-1200nm | Analysis 1 |
| Deliver system | Sapphire | Sapphire | SAME |
| Energy density | 1-50J/cm2 | 1-50J/cm2 | SAME |
| Pulse Width | 1-25ms | 1-25ms | SAME |
| Max. Power | 3500VA | 2200W | Analysis 5 |
| Spot size | Small: 40 x 12 mmLarge: 46 x 16mmEx-Large: 60 x 20mm | 12x30mm | Analysis 1 |
Table 9-2 Performance Comparison
Table 9-3 Setting Comparison of Specified Indication for Use
| ITEM | Proposed Device | Predicate DeviceIPL Therapy Machine VE2000(K161286) | Remark |
|---|---|---|---|
| hair removal | |||
| Wavelength Range(nm) | 640-1200 | 640-1200 | SAME |
| Energy Range(J/cm2) | 5 to 40 | 10-44 | SIMILAR |
| Pulse Width (ms) | 1-25 | 3-14 | Analysis 3 |
| Spot Size (mm) | Small: 40 x 12 mmLarge: 46 x 16mmEx-Large: 60 x 20mm | 12x30mm | Analysis 4 |
| pigmented lesions | |||
| Wavelength Range(nm) | 540-800 | 480-1200 | Analysis 1 |
| Energy Range(J/cm2) | 1-30 | 12-44 | Analysis 2 |
| Pulse Width (ms) | 1-20 | 3-9 | Analysis 3 |
| Spot Size (mm) | 40 x 12 mm | 12x30mm | Analysis 4 |
| vascular lesions | |||
| Wavelength Range(nm) | 520-650;800-1200 | 590-1200 | Analysis 1 |
| Energy Range(J/cm2) | 5-30 | 10-42 | Analysis 2 |
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| (J/cm2) | |||
|---|---|---|---|
| Pulse Width (ms) | 1-15 | 3-8 | Analysis 3 |
| Spot Size (mm) | 40 x 12 mm | 12x30mm | Analysis 4 |
Difference Analysis:
#1: Wavelength
The wavelength range of proposed devices is very closed to that of predicate devices. The slight difference is considered to have no negative effect on effectiveness and safety, and the bench tests conducted on the proposed device support substantial equivalence to the predicate device.
#2: Energy Range
The proposed device has an energy output range that is similar to the predicate device, and the slight differences do not result in negative safety and efficacy effects. The bench tests conducted on the proposed device support substantial equivalence to the predicate device.
#3: Pulse Width
The proposed device has a similar pulse width range as the predicate device. The slight difference in settings do not result in negative safety and effectiveness. The bench tests conducted on the proposed device support substantial equivalence to the predicate device.
#4: Spot Size
The proposed device has different spot size with the predicate device. However the differences in spot sizes are not considered to produce a negative effect on safety. The bench tests conducted on the proposed device support substantial equivalence to the predicate device.
#5 Max Power
The maximum input power of the proposed device is different from the predicate device. However, the proposed device conforms to IEC 60601-1 and IEC 60601-1-2 regarding device safety and electromagnetic compatibility
| ITEM | Proposed Device | Predicate DeviceIPL Therapy Machine VE2000(K161286) | Remark |
|---|---|---|---|
| Power supply | 110V, 60Hz or 230V, 50Hz | 110V 50Hz | Analysis 6 |
| ElectricalSafety | The proposed devices weretested to demonstrated tocomply with IEC 60601-1 | The proposed devices weretested to demonstrated tocomply with IEC 60601-1 | SE |
| EMC | The proposed devices weretested to demonstrated tocomply with IEC 60601-1-2 | The proposed devices weretested to demonstrated tocomply with IEC 60601-1-2 | SE |
Table 9-4 Safety Comparison
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| Patient ContactMaterial | Handpiece | Handpiece | SE |
|---|---|---|---|
| Biocompatibility | |||
| Cytotoxicity | No toxicity (ISO 10993-5) | No toxicity (ISO 10993-5) | SE |
| Irritation | Applied sample did not induce irritation to skin. (ISO 10993-10) | Applied sample did not induce irritation to skin. (ISO 10993-10) | SE |
| Sensitization | The test article showed no signification evidence of causing skin sensitization in the guinea pig .(ISO 10993-10) | The test article showed no signification evidence of causing skin sensitization in the guinea pig .(ISO 10993-10) | SE |
#6 Power Supply
The power supply of the proposed device is different from the predicate device. However, the proposed device conforms to IEC 60601-1 and IEC 60601-1-2 regarding device safety and electromagnetic compatibility.
9. 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.