(645 days)
The Diode laser therapy device is intended for delivery of laser light to soft tissue in the contact mode during surgical procedures. The device's 980mm laser is generally indicated for use in incision, vaporization, ablation, hemostasis or coagulation of soft tissue in ear, nose and throat and oral surgery (otolaryngology), dental procedures, gastroenterology, general surgery, dermatology, plastic surgery, podiatry, urology, gynecology. The device is further indicated for laser assisted lipolysis. The device's intended for delivery of laser light to soft tissue in non-contact mode during general surgery procedures, indicated for the treatment of reflux of the saphenous veins associated with varicose veins and varicosities.
The diode laser generates a 980nm wavelength laser to act on a target tissue to achieve resection, hemostasis, ablation, and coaqulation of the target tissue. The diode laser generates a 1470 nm wavelength laser that acts on the water molecules of the target tissue to achieve the function of treatment of reflux of the saphenous veins associated with varicose veins and varicosities. The Diode laser therapy device has following characteristics:
- Dual wavelengths A
- A Temperature monitoring system
The provided text describes a 510(k) submission for a Diode laser therapy device and its substantial equivalence to predicate devices, but it does not contain information about acceptance criteria for a performance study in terms of medical outcomes, nor does it detail a study proving device performance in a clinical context with human interaction.
Instead, the document focuses on non-clinical tests to establish safety and fundamental technical specifications.
Here's a breakdown of the requested information based on the provided text:
1. Table of acceptance criteria and the reported device performance
The document provides technical specifications and biocompatibility test results, which can be interpreted as fulfilling non-clinical acceptance criteria. These are compared against predicate devices.
| Item | Acceptance Criteria (from technical specifications and biocompatibility tests) | Reported Device Performance (Proposed Device) |
|---|---|---|
| Technical Specifications | ||
| Wavelength | 980nm±5nm, 1470nm±5nm | 980nm±5nm, 1470nm±5nm |
| Max Power | 16W/980nm±20%, 4.5W/1470nm±20%, 0.5mw/650nm | 16W/980nm±20%, 4.5W/1470nm±20%, 0.5mw/650nm |
| Security Level | Class IV type B | Class IV type B |
| Laser Output Mode | Continuous, Pulse, Single | Continuous, Pulse, Single |
| Pulse Width | 0.05ms-1s (stepping 0.05, 0.1ms) | 0.05ms-1s (stepping 0.05, 0.1ms) |
| Cooling | Air Cooling | Air Cooling |
| Size | 38×46.5×22.5cm | 38×46.5×22.5cm |
| Net Weight | 8KG | 8KG |
| Fuse | ⌀5×25, 2A | ⌀5×25, 2A |
| Laser Output Power | 16W/980nm±10%, 4.5W/1470nm±10%, 0.05mw/650nm (aiming beam) | 16W/980nm±10%, 4.5W/1470nm±10%, 0.05mw/650nm |
| Fiber Diameter | Φ400 | Φ400 |
| Aiming beam | 650 nm, red 0.5 mW, user controlled intensity | 650 nm, red 0.5 mW, user controlled intensity |
| Treatment mode (control) | Continuous, Pulse, Single | Continuous, Pulse, Single |
| Biocompatibility | ||
| Cytotoxicity | Noncytotoxic (Comply with ISO 10993-5) | Under the conditions of the study, the device is noncytotoxic. (Pass) |
| Irritation | Nonirritating (Comply with ISO 10993-10) | Under the conditions of the study, the device is nonirritating. (Pass) |
| Sensitization | Nonsensitizing (Comply with ISO 10993-10) | Under the conditions of the study, the device is nonsensitizing (Pass) |
| Acute systemic toxicity | No acute systemic toxicity (Comply with ISO 10993-11) | Under the conditions of the study, the device does show aucte systemic toxicity. (Pass) |
| Pyrogen test | No pyrogen (Comply with ISO 10993-11) | Under the conditions of the study, the device does show pyrogen. (Pass) |
| In vitro hemolytic test | No in vitro hemolytic risk (Comply with ISO 10993-4) | Under the conditions of the study, the device does show In vitro hemolytic risk. (Pass) |
| Electrical Safety | Comply with IEC 60601-1:2005+A1:2012, IEC 60825-1:2014, IEC 60601-2-22:2007+A1:2012 | Comply with IEC 60601-1:2005+A1:2012, IEC 60825-1:2014, IEC 60601-2-22:2007+A1:2012 |
| EMC | Comply with IEC 60601-1-2:2014 | Comply with IEC 60601-1-2:2014 |
The study that proves the device meets (these non-clinical) acceptance criteria:
The document refers to a "Non-Clinical Test Conclusion" (Section 7.0) and lists various tests, including:
- Performance testing: The technical specifications (Table 1) indicate measurement and verification of parameters like wavelength, max power, output mode, pulse width, cooling, size, weight, fuse, laser output power, fiber diameter, and aiming beam. The compliance with these specifications shows that the device meets its stated technical design and performance parameters.
- Biocompatibility testing: As detailed in Table 2, these tests were performed according to ISO standards:
- Cytotoxicity (ISO 10993-5)
- Irritation (ISO 10993-10)
- Sensitization (ISO 10993-10)
- Acute systemic toxicity (ISO 10993-11)
- Pyrogen test (ISO 10993-11)
- In vitro hemolytic test (ISO 10993-4)
- Electrical Safety & EMC testing: Compliance with IEC 60601-1_2005+A1_2012, IEC 60825-1_2014, IEC 60601-2-22_2007+A1_2012 for electrical safety and IEC 60601-1-2_2014 for EMC.
These non-clinical tests collectively form the "study" that proves the device meets the listed acceptance criteria for safety and basic functionality in a laboratory setting.
Regarding the other specific questions, the document states very clearly:
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 for clinical performance. The document explicitly states: "No clinical study implemented for the Diode laser therapy device." (Section 8.0).
- For the non-clinical tests (technical specs, biocompatibility, electrical safety, EMC), device units or material samples would have been used, but specific sample sizes and provenance for these types of engineering/laboratory tests are not provided in this summary.
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. No clinical ground truth was established as no clinical study was conducted.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. No clinical test set requiring adjudication was used.
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. This device is not an AI-assisted diagnostic or imaging device. No MRMC comparative effectiveness study was done.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This device is a laser therapy device, not an algorithm or AI system. Its performance is evaluated through direct technical and safety tests, not standalone algorithm performance.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not applicable for clinical performance. The "ground truth" for the non-clinical tests are international standards and predefined technical specifications (e.g., ISO 10993 series for biocompatibility, IEC 60601 series for electrical safety, stated power outputs, etc.).
8. The sample size for the training set
- Not applicable. This device is not an AI system that requires a "training set."
9. How the ground truth for the training set was established
- Not applicable. As above, no training set was used.
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June 6, 2023
Triangel Rsd Limited % Boyle Wang General Manager Shanghai Truthful Information Technology Co., Ltd. Room608,No.738,Shangcheng Rd.,Pudong Shanghai, Shanghai 200120 China
Re: K212734
Trade/Device Name: Diode laser therapy device 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: April 28, 2023 Received: May 1, 2023
Dear Boyle 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.
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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.
Jianting Wang -S
Jianting Wang 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) K212734
Device Name Diode laser therapy device
Indications for Use (Describe)
The Diode laser therapy device is intended for delivery of laser light to soft tissue in the contact mode during surgical procedures. The device's 980mm laser is generally indicated for use in incision, vaporization, ablation, hemostasis or coagulation of soft tissue in ear, nose and throat and oral surgery (otolaryngology), dental procedures, gastroenterology, general surgery, dermatology, plastic surgery, podiatry, urology, gynecology. The device is further indicated for laser assisted lipolysis. The device's intended for delivery of laser light to soft tissue in non-contact mode during general surgery procedures, indicated for the treatment of reflux of the saphenous veins associated with varicose veins and varicosities.
| 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
510(k) number: K212734
This summary of 510(k) safety and effectiveness information is being submitted in accordance with requirements of SMDA 1990 and 21 CFR 807.92.
1.0 Submitter's information
Name: TRIANGEL RSD LIMITED Address: Center Building 4, C Unit 324, #3088, Lekai North Street, Power Valley Technology, Baoding City, Heibei, China Phone Number: 86-18931273229 Contact: Zhao Fengdan Email: triangelrsd@triangelaser.com Date of Preparation: Jun.02, 2023
Prior submissions
This is the first submission, there is no prior submission.
Designated Submission Correspondent
Mr. Boyle Wang Shanghai Truthful Information Technology Co., Ltd. Room 608, No. 738 Shangcheng Rd., Pudong Shanghai, 200120 China Tel: +86-21-50313932 Email: Info@truthful.com.cn
2.0 Device information
| Trade name: | Diode laser therapy device |
|---|---|
| Common name: | Powered Laser Surgical Instrument |
| Regulation name: | Laser surgical instrument for use in general and plastic surgeryand in dermatology |
| Model(s): | ST-AR. |
3.0 Classification
Production code: GEX Regulation number: 21 CFR 878.4810 Classification: Class II General & Plastic Surgery Panel:
4.0 Predicate device information
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510(k) Number: K081015 Product Name: Ceralas Diode 980nm Laser System Manufacturer: Biolitec, Inc.
510(k) Number: K073063 Product Name: 15W Ceralas Diode 1470nm Laser System Manufacturer: Biolitec, Inc.
5.0 Indication for Use Statement
The Diode laser therapy device is intended for delivery of laser light to soft tissue in the contact and non contact mode during surgical procedures. The device's 980nm laser is generally indicated for use in incision, excision, vaporization, ablation, hemostasis or coagulation of soft tissue in ear, nose and throat and oral surgery (otolaryngology), dental procedures, gastroenterology, general surgery, dermatology, plastic surgery, podiatry, urology, gynecology. The device is further indicated for laser assisted lipolysis. The device's 1470nm laser is intended for delivery of laser light to soft tissue in non-contact mode during general surgery procedures, indicated for the treatment of reflux of the saphenous veins associated with varicose veins and varicosities.
6.0 Device description
The diode laser generates a 980nm wavelength laser to act on a target tissue to achieve resection, hemostasis, ablation, and coaqulation of the target tissue. The diode laser generates a 1470 nm wavelength laser that acts on the water molecules of the target tissue to achieve the function of treatment of reflux of the saphenous veins associated with varicose veins and varicosities. The Diode laser therapy device has following characteristics:
- Dual wavelengths A
- A Temperature monitoring system
7.0 Non-Clinical Test Conclusion
| Item | Technical specification |
|---|---|
| Wavelength | 980nm±5nm, 1470nm±5nm |
| Max Power | 16W/980nm±20%, 4.5W/1470nm±20%, 0.5mw/650nm |
| Security Level | Class IV type B |
| Laser Output Mode | Continuous, Pulse, Single. |
| Pulse Width | 0.05ms-1s (stepping 0.05, 0.1ms) |
| Cooling | Air Cooling |
| Size | 38×46.5×22.5cm |
| Net Weight | 8KG |
| Fuse | ⌀5×25, 2A |
| Laser Output Power | 16W/980nm±10%, 4.5W/1470nm±10% |
Table 1 - Product Technical Specification
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| 0.05mw/650nm | |
|---|---|
| Fiber Diameter | Φ400 |
| Aiming beam | 650 nm, red 0.5 mW, user controlled intensity |
| Treatment mode | Continuous, Pulse, Single. |
Table 2 - Biocompatibility testing for components contacting patients
| Item | Proposed Device | Result |
|---|---|---|
| Cytotoxicity | Under the conditions of the study, the device is noncytotoxic. | Pass |
| Irritation | Under the conditions of the study, the device is nonirritating. | Pass |
| Sensitization | Under the conditions of the study, the device is nonsensitizing | Pass |
| Aucte systemic toxicity, | Under the conditions of the study, the device does show aucte systemic toxicity | Pass |
| Pyrogen test | Under the conditions of the study, the device does show pyrogen | Pass |
| In vitro hemolytic test | Under the conditions of the study, the device does show In vitro hemolytic risk | Pass |
8.0 _Clinical Test Conclusion
No clinical study implemented for the Diode laser therapy device.
9.0 Technological Characteristic Comparison Table
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| Item | Proposed device | Predicated device | Remark | |
|---|---|---|---|---|
| Product Code | GEX | GEX | Identical | |
| Regulation No. | 21 CFR 878.4810 | 21 CFR 878.4810 | Identical | |
| Class | II | II | Identical | |
| Product name | Diode laser therapy device | Ceralas Diode 980nm Laser System | 15W Ceralas Diode 1470nmLaser System | |
| 510(k) No. | K212734 | K081015 | K073063 | - |
| Models | ST-AR | D15 | D1470 | - |
| Intended use | The Diode laser therapy device isintended for delivery of laser light to softtissue in the contact and non contactmode during surgical procedures. Thedevice's 980nm laser is generallyindicated for use in incision, excision,vaporization, ablation, hemostasis orcoagulation of soft tissue in ear, nose andthroat and oral surgery (otolaryngology),dental procedures, gastroenterology,general surgery, dermatology, plasticsurgery, podiatry, urology, gynecology.The device is further indicated for laserassisted lipolysis. | The Ceralas D 980 is intended fordelivery of laser light to soft tissue in thecontact or noncontact mode duringsurgical procedures, including viaendoscopes, introducers, or catheters.The Ceralas D 980 is generally indicatedfor incision, excision, vaporization,ablation, hemostasis, or coagulation ofsoft tissue in ear, nose and throat andoral surgery (otolaryngology), dentalprocedures, arthroscopy,gastroenterology, general surgery,dermatology, plastic surgery,podiatry, urology, gynecology,neurosurgery (peripheral nervoussystem), pulmonary surgery, andcardiothoracic surgery, and | * Gap 1 |
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| ophthalmology. This Ceralas D 980 isspecifically indicated for laser assistedlipolysis. | ||||
|---|---|---|---|---|
| The device's 1470nm laser is intendedfor delivery of laser light to soft tissue innon-contact mode during general surgeryprocedures, indicated for the treatment ofreflux of the saphenous veins associatedwith varicose veins and varicosities. | The Ceralas D1470 is a diodelaser that is intended for deliveryof laser light to soft tissue innon-contact mode duringgeneral surgery procedures.The device is indicated for thetreatment of reflux of thesaphenous veins associatedwith varicose veins andvaricosities. | Same | ||
| PatientPopulation | Adult | Adult | Adult | Same |
- Gap analysis:
Gap 1: The proposed device does not use with the endoscope, the indication of Arthroscopy, Cardiothoracic Surgery, Neurosurgery, treatment of reflux of the saphenous veins and varicosities, which the predicate device applies does not apply to the proposed device, less indication will not bring additional risks to the proposed device.
Gap 2: The proposed device defines specific contraindication which does not bring additional clinical risk for the product use.
Table 4- Performance Comparison
| Item | Proposed Device | Predicate Device | Remark |
|---|---|---|---|
| Diode laser therapy device | Ceralas Diode 980nm Laser System15W Ceralas Diode 1470nm LaserSystem | ||
| K212734 | K081015K073063 |
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| Wavelength | 980nm±5nm,1470nm±10nm | 980 nm | 1470 nm | Same |
|---|---|---|---|---|
| Output Power max. | 16W/980nm±20%,4.5W/1470nm±20% | 15 Watt | 15 Watt | * Gap 2 |
| Aiming beam | 650 nm, red 0.5 mW, usercontrolled intensity | 635 nm, red 4 mW, user controlledintensity | 635 nm, red 4 mW, user controlledintensity | * Gap 3 |
| Treatment mode | Continuous or Pulsed | Continuous or Pulsed | Continuous or Pulsed | Same |
| Power supply | AC110V±11V, 60HZ | 110/220 V | 110/220 V | * Gap 4 |
| Interval | 980nm 1% ~ 100%,1470nm 2% ~100%,continuously adjustableenergy | 980nm 1% ~ 100%, continuouslyadjustable energy | 1470nm 2% ~100%, continuouslyadjustable energy | Same |
| Cooling system | Air cooled | Air cooled | Air cooled | Same |
| Fiber (applied part) | Sterile, for single use | Single use or repeated use | Single use or repeated use | * Gap 5 |
- Gap analysis:
Gap 2, the 980nm max power of the proposed device is close to the predicate device, which does not create additional risk to the product use. For 1470m max power of the proposed device is different to the predicate device, we collect clinical survey data, and clinical literature which can support the efficacy of the 4.5W is effective to realize its intended performance, the lower 4.5W can risks compared to predicate device.
Gap 3, the aiming beam of the two device are close, which difference does not create additional risks to the product clinical use.
Gap 4, the power supply range of the proposed device is included in the predicate device.
Gap 5, the fiber (applied part) of the proposed device is for single use, sterile, which will not create addtional risks compared to the equivalence device.
Table 5- Safety Comparison
| Item | Proposed Device | Predicate Device | Remark |
|---|---|---|---|
| ------ | ----------------- | ------------------ | -------- |
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| Diode laser therapy device | Ceralas Diode 980nm LaserSystem | 15W Ceralas Diode 1470nmLaser System | ||
|---|---|---|---|---|
| K212734 | K081015 | K073063 | ||
| Materialscontacting user | Fiber | Fiber | Fiber | Same |
| Biocompatibility ofmaterialscontacting user | Cytotoxicity, Comply with ISO10993-5;Irritation, Sensitization, complywith ISO 10993-10;Aucte systemic toxicity,Pyrogen test comply with ISO10993-11;In vitro hemolytic test complywith ISO 10993-4. | Cytotoxicity, Comply with ISO10993-5;Irritation, Sensitization, complywith ISO 10993-10 | Cytotoxicity, Comply with ISO10993-5;Irritation, Sensitization, complywith ISO 10993-10 | Gap 6 |
| Electric safety | Comply with IEC60601-1:2005+A1:2012, IEC60825-1:2014,IEC 60601-2-22:2007+A1:2012 | Comply with IEC 60601-1, IEC60825-1, IEC 60601-2-22 | Comply with IEC 60601-1, IEC60825-1, IEC 60601-2-22 | Same |
| EMC | Comply with IEC60601-1-2:2014 | Comply with IEC 60601-1-2 | Comply with IEC 60601-1-2 | Same |
- Gap analysis:
Gap 6: the proposed device implement more biccompatibility study for the device, which does not create additional risks for product use
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10.0 Conclusion
The conclusion drawn from the nonclinical tests demonstrates that the subject device in 510(K) submission, the Diode laser therapy device is as safe, as effective, and performs as well as or better than the legally marketed predicate device cleared under K081015, K073063.
§ 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.