(59 days)
The SIROLaser Blue is intended for:
(970 nm and 445 nm): intra- and extra-oral surgery including incision, hemostasis, coagulation and vaporization of soft tissue including marginal and epithelial lining of free gingiva and is indicated for: frenectomy; frenotomy; biopsy; operculectomy; imglant recovery; gingivoplasty; gingival troughing; crown lengthening; hemostasis of donor site; removal of granulation tissue; laser assisted flap surgery; debridement of diseased epithelial lining; incisions and draining of abscesses; tissue retraction for impressions; papillectomy; vestibuloplasty ; excision of lesions; exposure of unerupted teeth: removal of hyperplastic tissues: treatment of aphthous ulcers; leukoplakia; laser removal of diseased, inflamed and necrosed soft tissue within the periodontal pocket; sulcular debridement (removal of diseased, inflamed and necrosed soft tissue in the periodontal pocket to improve clinical indices including gingival index, gingival bleeding index, probe depth, attachment loss and tooth inability); pulpotomy; pulpotomy as adjunct to root canal therapy; fibroma removal; gingival incision; treatment of canker sores; herpetic ulcers of the oral mucosa; laser soft tissue curettage; reduction of gingival hypertrophy.
Whitening (970 nm and 445 nm): The SIROLaser Blue is indicated for light activation for bleaching materials for teeth whitening and for laser-assisted whitening/bleaching of teeth.
Low Level Laser Therapy (660 nm and 970 nm): The SIROLaser Blue is intended to emit energy in the red and infrared spectrum to provide topical heating for the purpose of elevating tissue temperature for the for minor muscle and joint pain and stiffness, minor arthritis pain, and for the temporary increase in local blood circulation and/or temporary relaxation of muscles.
The SIROLaser Blue is a solid state laser device in which laser energy is generated by internal diodes. The laser output energy of the device is in the infrared, red, and blue spectra at wavelengths of 970 nm, 660nm, and 445 nm respectively. The output settings of the SIROLaser Blue can be adjusted by the user.
SIROLaser Blue primarily consists of a laser control unit with graphical touch screen user interface, a laser handpiece, single-use, disposable, "EasyTip" laser fiber guides (for surgical applications), and reusable "MultiTip" light guides (for non-contact, low-power, "soft laser" applications). The laser control unit contains the 970 nm, 660 mm, and 445 nm laser diodes, electronic hardware, touchscreen graphical user interface, and software to control the laser functionality.
The SIROLaser Blue handpiece assembly consists of an internal handpiece body with laser activation finger switch. The handpiece includes a removable stainless steel outer sleeve which can be cleaned and sterilized between patient procedures. The SIROLaser Blue is also offered with an optional wireless footswitch.
This document describes the non-clinical performance data for the SIROLaser Blue device (K180044). The information provided is primarily focused on engineering and safety compliance testing rather than diagnostic performance or comparative effectiveness with human readers.
Here's an analysis based on the provided text, addressing your points where information is available:
1. Table of Acceptance Criteria and Reported Device Performance:
The document doesn't explicitly present a table of acceptance criteria with specific numerical performance metrics for the device's functional use (e.g., cutting speed, tissue vaporisation rate). Instead, it lists the standards the device was tested against and claims conformity. The only performance data mentioned directly relates to "cutting efficiency."
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Conformity with IEC 60601-1 (Basic safety and essential performance) | Testing conducted and verified conformity. |
| Conformity with IEC 60601-1-2 (Electromagnetic compatibility) | Testing conducted and verified conformity. |
| Conformity with IEC 60825-1 (Laser product safety) | Testing conducted and verified conformity. |
| Conformity with IEC 60601-2-22 (Surgical laser equipment) | Testing conducted and verified conformity. |
| Conformity with IEC 62366 (Usability engineering) | Usability study conducted in conformity. |
| Conformity with IEC 62304 (Medical device software lifecycle) | Validation of the device's software in conformity. |
| Equivalent cutting efficiency of 445 nm laser wavelength with 970 nm laser wavelength | Published bench test data summarized to show comparable cutting efficiency (histological examination of cutting depth and tissue denaturation). |
| Biocompatibility of patient-contacting accessories | Patient-contacting accessories are identical to predicate device; no new testing performed for substantial equivalence. |
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size:
- For the cutting efficiency study: The document mentions "summarize studies conducted utilizing the SIROLaser Blue device comparing the cutting efficiency of the 445 nm laser wavelength... with the 970 nm laser wavelength." It doesn't specify the sample size of tissue specimens or tests performed.
- For other conformity tests (IEC standards, usability, software validation): The sample sizes are not explicitly stated. These typically involve testing of device units and system components rather than patient data.
- Data Provenance: The document does not specify the country of origin. The bench tests described are non-clinical and would have been conducted in a laboratory setting. All data is retrospective to the submission date.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
- For the cutting efficiency study: The ground truth was established through "histological examination of cutting depth and tissue denaturation." This implies the involvement of experts in histology or pathology for evaluating the tissue samples. However, the specific number of experts and their qualifications (e.g., "pathologist with X years of experience") are not mentioned.
- For other conformity tests: These are engineering and safety tests, and while experts would be involved in conducting and interpreting them, the nature of "ground truth" and "experts" as understood in clinical diagnostic studies is not directly applicable here.
4. Adjudication Method for the Test Set:
- The document does not mention any adjudication method like 2+1 or 3+1. For the cutting efficiency study, the histological examination would likely be a direct measurement or a consensus among histologists if multiple were involved, but this is not detailed.
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:
- No MRMC comparative effectiveness study was done. This device is a laser surgical instrument, not an AI-assisted diagnostic or decision-support system. The study described is a non-clinical bench test comparing the physical cutting performance of different laser wavelengths.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:
- This question is not applicable as the SIROLaser Blue is a physical medical device (a laser surgical instrument), not a software algorithm or AI. The "standalone" performance described refers to the device's intrinsic physical characteristics and safety compliance, as opposed to its performance in conjunction with human interpretation of data.
7. The Type of Ground Truth Used:
- For the cutting efficiency study: The ground truth was established through histological examination of tissue samples to assess cutting depth and tissue denaturation. This is a direct, objective measurement from pathological assessment of the treated tissue.
- For other non-clinical tests (IEC standards, usability, software validation): The "ground truth" refers to compliance with the requirements of the respective standards and specifications, confirmed through various engineering tests and validations.
8. The Sample Size for the Training Set:
- Not applicable. This device is a physical laser instrument. There is no "training set" in the context of machine learning or AI algorithms to improve its performance. Its functionality is based on its physical design and laser parameters, validated through engineering tests.
9. How the Ground Truth for the Training Set Was Established:
- Not applicable. As there is no training set for an algorithm, there is no ground truth established for a training set.
In summary: The provided document is a 510(k) summary for a physical medical device. The "study" mentioned is a non-clinical bench test designed to demonstrate the equivalence of a new laser wavelength's cutting efficiency to an existing one, alongside various engineering and safety compliance tests. The concepts of AI performance metrics, human reader studies, and training/test sets for algorithms are not relevant to this type of device submission.
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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters 'FDA' in a blue square, followed by the words 'U.S. FOOD & DRUG ADMINISTRATION' in blue text.
March 8, 2018
Dentsply Sirona Karl Nittinger Senior Manager, Corporate Regulatory Affairs 221 West Philadelphia Street Suite 60W York, Pennsylvania 17401
Re: K180044
Trade/Device Name: SIROLaser Blue 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: March 8, 2018 Received: March 8, 2018
Dear Karl Nittinger:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing, 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); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm_for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Jennifer R. Stevenson -S3
For Binita S. Ashar, M.D., M.B.A., F.A.C.S. Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K180044
Device Name SIROLaser Blue
Indications for Use (Describe)
The SIROLaser Blue is intended for:
(970 nm and 445 nm): intra- and extra-oral surgery including incision, hemostasis, coagulation and vaporization of soft tissue including marginal and epithelial lining of free gingiva and is indicated for: frenectomy; frenotomy; biopsy; operculectomy; imglant recovery; gingivoplasty; gingival troughing; crown lengthening; hemostasis of donor site; removal of granulation tissue; laser assisted flap surgery; debridement of diseased epithelial lining; incisions and draining of abscesses; tissue retraction for impressions; papillectomy; vestibuloplasty ; excision of lesions; exposure of unerupted teeth: removal of hyperplastic tissues: treatment of aphthous ulcers; leukoplakia; laser removal of diseased, inflamed and necrosed soft tissue within the periodontal pocket; sulcular debridement (removal of diseased, inflamed and necrosed soft tissue in the periodontal pocket to improve clinical indices including gingival index, gingival bleeding index, probe depth, attachment loss and tooth inability); pulpotomy; pulpotomy as adjunct to root canal therapy; fibroma removal; gingival incision; treatment of canker sores; herpetic ulcers of the oral mucosa; laser soft tissue curettage; reduction of gingival hypertrophy.
Whitening (970 nm and 445 nm): The SIROLaser Blue is indicated for light activation for bleaching materials for teeth whitening and for laser-assisted whitening/bleaching of teeth.
Low Level Laser Therapy (660 nm and 970 nm): The SIROLaser Blue is intended to emit energy in the red and infrared spectrum to provide topical heating for the purpose of elevating tissue temperature for the for minor muscle and joint pain and stiffness, minor arthritis pain, and for the temporary increase in local blood circulation and/or temporary relaxation of muscles.
| 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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SECTION 5. 510(k) SUMMARY for
SIROLaser Blue
1. Submitter Information:
Dentsply Sirona 221 West Philadelphia Street Suite 60 York, PA 17404
| Contact Person: | Karl Nittinger |
|---|---|
| Telephone Number: | 717-849-4424 |
| Fax Number: | 717-849-4343 |
March 8, 2018 Date Prepared:
2. Device Name:
- Proprietary Name: SIROLaser Blue ● Laser surgical instrument for use in general and Classification Name: . plastic surgery and in dermatology. 21 CFR 878.4810 CFR Number: .
| • Device Class: | Class II |
|---|---|
| • Product Code: | GEX (Powered Laser Surgical Instrument) |
| ILY (Lamp, Infrared, Therapeutic Heating) |
3. Predicate Device:
The predicate and reference devices identified relating to the substantial equivalence of the SIROLaser Blue are:
| Primary Predicate Device Name | 510(k) | Company Name |
|---|---|---|
| SIROLaser Advance+ | K170500 | Dentsply Sirona |
| Secondary Predicate Device Name | 510(k) | Company Name |
| SIROLaser Advance | K103753 | Sirona Dental Systems GmbH |
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4. Description of Device:
The SIROLaser Blue is a solid state laser device in which laser energy is generated by internal diodes. The laser output energy of the device is in the infrared, red, and blue spectra at wavelengths of 970 nm, 660nm, and 445 nm respectively. The output settings of the SIROLaser Blue can be adjusted by the user.
SIROLaser Blue primarily consists of a laser control unit with graphical touch screen user interface, a laser handpiece, single-use, disposable, "EasyTip" laser fiber guides (for surgical applications), and reusable "MultiTip" light guides (for non-contact, low-power, "soft laser" applications). The laser control unit contains the 970 nm, 660 mm, and 445 nm laser diodes, electronic hardware, touchscreen graphical user interface, and software to control the laser functionality.
The SIROLaser Blue handpiece assembly consists of an internal handpiece body with laser activation finger switch. The handpiece includes a removable stainless steel outer sleeve which can be cleaned and sterilized between patient procedures. The SIROLaser Blue is also offered with an optional wireless footswitch.
5. Indications for Use:
The SIROLaser Blue is intended for:
(970nm and 445nm): intra- and extra-oral surgery including incision, excision, hemostasis, coagulation and vaporization of soft tissue including marginal and inter-dental and epithelial lining of free gingiva and is indicated for: frenectomy; frenotomy; biopsy; operculectomy; implant recovery; gingivectomy; gingivoplasty; gingival troughing; crown lengthening; hemostasis of donor site; removal of granulation tissue; laser assisted flap surgery; debridement of diseased epithelial lining; incisions and draining of abscesses; tissue retraction for impressions; papillectomy; vestibuloplasty ; excision of lesions; exposure of unerupted/partially erupted teeth; removal of hyperplastic tissues; treatment of aphthous ulcers; leukoplakia; laser removal of diseased, inflamed and necrosed soft tissue within the periodontal pocket; sulcular debridement (removal of diseased, inflamed and necrosed soft tissue in the periodontal pocket to improve clinical indices including gingival index, gingival bleeding index, probe depth, attachment loss and tooth inability); pulpotomy; pulpotomy as adjunct to root canal therapy; fibroma removal; gingival incision and excision; treatment of canker sores; herpetic ulcers of the oral mucosa; laser soft tissue curettage; reduction of gingival hypertrophy.
Whitening (970nm and 445nm): The SIROLaser Blue is indicated for light activation for bleaching materials for teeth whitening and for laser-assisted whitening/bleaching of teeth.
Low Level Laser Therapy (660nm and 970nm): The SIROLaser Blue is intended to emit energy in the red and infrared spectrum to provide topical heating for the purpose of elevating tissue temperature for the temporary relief of minor muscle and joint pain and stiffness, minor arthritis pain, or muscle spasm, and for the temporary increase in local blood circulation and/or temporary relaxation of muscles.
Denstply Sirona SIROLaser Blue
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6. Substantial Equivalence:
The subject SIROLaser Blue has the same intended use as the predicate device. Both the SIROLaser Blue and the primary predicate device are intended as powered laser surgical instruments as well as to provide topical heating to soft tissues for therapeutic purposes under 21 CFR 878.4810 and 21 CFR 890.5500, respectively.
The subject SIROLaser Blue and the primary predicate device (K170500) both generate laser energy via solid state LED technology. As does the primary predicate device (K170500), the subject SIROLaser Blue emits laser light energy in both the infrared and red spectra.
In addition to laser energy in the infrared and red spectra, the subject SIROLaser Blue also emits laser energy in the blue (445 nm) spectrum. The secondary predicate SIROLaser Advance (K103753) is included in the technological comparison because published performance bench testing which verified the equivalency of the cutting efficiency of the 445 mm laser wavelength compared to that of the 970 nm laser wavelength is included in this premarket notification to support substantial equivalence. The bench test performance verification was conducted utilizing the subject SIROLaser Blue (445 nm) and the secondary predicate SIROLaser Advance (K103753) device (970 nm) and compared soft tissue cutting performance.
The SIROLaser Blue and the predicate device are intended for surgical applications using handpieces to which single-use laser fiber tips are attached. For low-level laser therapy applications, both the SIROLaser Blue and the predicate device offer non-contact handpieces.
Detailed comparison of the intended use, indications for use, and design of the SIROLaser Blue and the predicate device is presented in Tables 6.1 and 6.2.
| Proposed DeviceSIROLaser Blue | Primary Predicate DeviceSIROLaser Advance+(K170500) | Secondary Predicate DeviceSIROLaser Advance(K103753) |
|---|---|---|
| Surgical Indications for Use | ||
| Intended for intra- and extra-oral surgeryincluding incision, excision, hemostasis,coagulation and vaporization of soft tissueincluding marginal and inter-dental andepithelial lining of free gingiva and isindicated for: | Intended for intra- and extra-oralsurgery including incision, excision,hemostasis, coagulation andvaporization of soft tissue includingmarginal and inter-dental and epitheliallining of free gingiva and is indicatedfor: | Intended for intra- and extra-oralsurgery including incision,excision, hemostasis, coagulationand vaporization of soft tissueincluding marginal and inter-dental and epithelial lining of freegingiva and is indicated for: |
| frenectomy; frenotomy; | frenectomy; frenotomy; | frenectomy; frenotomy; |
| biopsy; operculectomy; | biopsy; operculectomy; | biopsy; operculectomy; |
| implant recovery; | implant recovery; | implant recovery; |
| gingivectomy; gingivoplasty; | gingivectomy; gingivoplasty; | gingivectomy; gingivoplasty; |
| gingival troughing; | gingival troughing; | gingival troughing; |
| crown lengthening; | crown lengthening; | crown lengthening; |
| hemostasis of donor site; | hemostasis of donor site; | hemostasis of donor site; |
| Proposed DeviceSIROLaser Blue | Primary Predicate DeviceSIROLaser Advance+(K170500) | Secondary Predicate DeviceSIROLaser Advance(K103753) |
| Surgical Indications for Use (continued) | ||
| removal of granulation tissue; | removal of granulation tissue; | removal of granulation tissue; |
| laser assisted flap surgery; | laser assisted flap surgery; | laser assisted flap surgery; |
| debridement of diseased epithelial lining; | debridement of diseased epithelial lining; | debridement of diseased epitheliallining; |
| incisions and draining of abscesses; | incisions and draining of abscesses; | incisions and draining ofabscesses; |
| tissue retraction for impressions; | tissue retraction for impressions; | tissue retraction for impressions; |
| papillectomy; vestibuloplasty; | papillectomy; vestibuloplasty; | papillectomy; vestibuloplasty; |
| excision of lesions; | excision of lesions; | excision of lesions; |
| exposure of unerupted/partially eruptedteeth; | exposure of unerupted/partially eruptedteeth; | exposure of unerupted/partiallyerupted teeth; |
| removal of hyperplastic tissues; | removal of hyperplastic tissues; | removal of hyperplastic tissues; |
| treatment of aphthous ulcers; | treatment of aphthous ulcers; | treatment of aphthous ulcers; |
| leukoplakia; | leukoplakia; | leukoplakia; |
| pulpotomy; pulpotomy as adjunct to rootcanal therapy; | pulpotomy; pulpotomy as adjunct to rootcanal therapy; | pulpotomy; pulpotomy as adjunctto root canal therapy; |
| fibroma removal; gingival incision andexcision; | fibroma removal; gingival incision andexcision; | fibroma removal; gingivalincision and excision; |
| treatment of canker sores; herpetic ulcersof the oral mucosa; | treatment of canker sores; herpetic ulcersof the oral mucosa; | treatment of canker sores; herpeticulcers of the oral mucosa; |
| laser soft tissue curettage; | laser soft tissue curettage; | laser soft tissue curettage; |
| reduction of gingival hypertrophy. | reduction of gingival hypertrophy. | reduction of gingival hypertrophy. |
| Laser Periodontic Indications for Use | ||
| laser removal of diseased, infected,inflamed and necrosed soft tissue; withinthe periodontal pocket; | laser removal of diseased, infected,inflamed and necrosed soft tissue; withinthe periodontal pocket; | laser removal of diseased,infected, inflamed and necrosedsoft tissue; within the periodontalpocket; |
| sulcular debridement (removal of diseased,infected, inflamed and necrosed soft tissuein the periodontal pocket to improveclinical indices including gingival index,gingival bleeding index, probe depth,attachment loss and tooth inability); | sulcular debridement (removal ofdiseased, infected, inflamed and necrosedsoft tissue in the periodontal pocket toimprove clinical indices includinggingival index, gingival bleeding index,probe depth, attachment loss and toothinability); | sulcular debridement (removal ofdiseased, infected, inflamed andnecrosed soft tissue in theperiodontal pocket to improveclinical indices including gingivalindex, gingival bleeding index,probe depth, attachment loss andtooth inability); |
| Tooth Whitening Indications for Use | ||
| Light activation for bleaching materials forteeth whitening; | Light activation for bleaching materialsfor teeth whitening; | N/A |
| Laser-assisted whitening/bleaching ofteeth | Laser-assisted whitening/bleaching ofteeth | N/A |
Table 6.1: Indications for Use
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| Table 6.1 (continued): Indications for Use | ||
|---|---|---|
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Table 6.1 (continued): Indications for Use
| Proposed DeviceSIROLaser Blue | Primary Predicate DeviceSIROLaser Advance+(K170500) | Secondary Predicate DeviceSIROLaser Advance(K103753) |
|---|---|---|
| Low Level Laser Therapy Indications for Use | ||
| Intended to emit energy in the red andinfrared spectrum to provide topicalheating for the purpose of elevating tissuetemperature for the temporary relief ofminor muscle and joint pain and stiffness,minor arthritis pain, or muscle spasm, andfor the temporary increase in local bloodcirculation and/or temporary relaxation ofmuscles. | Intended to emit energy in the infraredspectrum to provide topical heating for thepurpose of elevating tissue temperaturefor the temporary relief of minor muscleand joint pain and stiffness, minor arthritispain, or muscle spasm, the temporaryincrease in local blood circulation and/ortemporary relaxation of muscles. | N/A |
Table 6.2: Design
| Proposed DeviceSIROLaser Blue | Primary Predicate DeviceSIROLaser Advance+(K170500) | Secondary Predicate DeviceSIROLaser Advance(K103753) |
|---|---|---|
| Laser Classification | ||
| 970 nm and 445 nm Laser: Class IV | 970 nm Laser: Class IV | 970 nm: Class IV |
| 660 nm Laser: Class II | 660 nm Laser: Class II | |
| Laser Type | ||
| Solid state diode laser | Solid state diode laser | Solid state diode laser |
| Laser Wavelength | ||
| 970 nm | 970 nm | 970 nm |
| 660 nm | 660 nm | |
| 445 nm | ||
| Optical Power | ||
| 970 nm:0.2 W - 2.0 W (Continuous Wave) | 970 nm:0.2 W - 7.0 W (Continuous Wave)14 W (peak optical power) | 970 nm:7.0 W max. (Continuous Wave)14 W (peak optical power) |
| 660 nm:25 mW, 50 mW, 100 mW (ContinuousWave) | 660 nm:25 mW, 50 mW, 100 mW (ContinuousWave) | |
| 445 nm:0.2 W - 3.0 W (Continuous Wave) | ||
| · Continuous Wave· Chopped (1 Hz - 10 kHz) | · Continuous Wave· Chopped (1 Hz - 10 kHz)· Peak Pulse (1.5 kHz – 20 kHz) | · Continuous Wavre· Chopped (1 Hz - 10 kHz)· Peak Pulse (up to 20 kHz) |
| Chopped Mode: | Chopped Mode: 10 usec. to 0.99 sec. | Chopped Mode: 10 usec. to 0.99 sec. |
| 10 µsec. to 0.99 sec. | Peak Pulse: 23 µsec. | Peak Pulse: 23 µsec. |
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| Table 6.2 (continued): Design | ||
|---|---|---|
| Proposed DeviceSIROLaser Blue | Primary Predicate DeviceSIROLaser Advance+(K170500) | Secondary Predicate DeviceSIROLaser Advance(K103753) |
|---|---|---|
| Aiming Beam | ||
| 660 nm1 mW (max.) | 660 nm1 mW (max.) | 635 nm – 650 nm1 mW (max) |
| Optical Fiber Surgical Tips | ||
| Fiber Diameter:200 μm, 320 μm | Fiber Diameter:200 μm, 320 μm | Fiber Diameter:200 μm, 320 μm |
| • Single-use tips.• Integral laser fiber.• Plastic proximal connection hub.• Bendable stainless steel cannula.• Provided sterile(sterilized by ethylene oxide). | • Single-use tips.• Integral laser fiber.• Plastic proximal connection hub.• Bendable stainless steel cannula.• Provided sterile(sterilized by ethylene oxide). | • Single-use tips.• Laser fiber assembled with tip byuser.• Plastic proximal connection hub.• Bendable stainless steel cannula.• Provided non-sterile. |
| Laser Handpiece | ||
| • Handpiece connected by flexibleoptical fiber to control unit.• Finger switch laser activation.• Removable, sterilizable stainless steelouter sleeve. | • Handpiece connected by flexible opticalfiber to control unit.• Finger switch laser activation.• Removable, sterilizable stainless steelouter sleeve. | • Handpiece connected by flexibleoptical fiber to control unit.• Finger switch laser activation.• Removable, sterilizable outersleeve. |
| Laser Therapy Light Guides | ||
| Curved light guides:4 mm, 8mm diameter. | Curved light guides:4 mm, 8mm diameter. | N/A |
| Activation Method | ||
| • Handpiece finger switch.• Optional wireless foot switch. | • Handpiece finger switch.• Optional wireless foot switch. | • Handpiece finger switch.• Optional wireless foot switch. |
| Laser Control Unit Dimensions | ||
| 182 mm x 197 mm x 189 mm | 182 mm x 197 mm x 189 mm | 182 mm x 197 mm x 189 mm |
| Laser Control Unit User Interface | ||
| Color touch screen graphical userinterface. | Color touch screen graphical user interface. | Color touch screen graphical userinterface. |
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7. Non-Clinical Performance Data
The Testing to verify the performance requirements of the SIROLaser Blue was conducted and included in this premarket notification. The results of the performance testing support substantial equivalence.
Tests included in this premarket notification:
- · Testing to verify the conformity of the proposed SIROLaser Blue with the requirements of IEC 60601-1: (Medical electrical equipment Part 1: General requirements for basic safety and essential performance).
- . Testing to verify the conformity of the proposed SIROLaser Blue with the requirements of IEC 60601-1-2: (Medical electrical equipment Part 1-2: General requirements for basic safety and essential performance. Collateral Standard: Electromagnetic compatibility).
- . Testing to verify the conformity of the proposed SIROLaser Blue to IEC 60825-1 (Safety of laser products – Part 1: Equipment classification and requirements).
- . Testing to verify the performance of the proposed SIROLaser Blue according to IEC 60601-2-22: (Medical electrical equipment Part 2: Particular Requirements for basic safety and essential performance of surgical, cosmetic, therapeutic, and diagnostic laser equipment).
- . Usability study conducted in conformity with IEC 62366 (Medical devices – Application of usability engineering to medical devices).
- Statement confirming that the patient-contacting accessories of the subject SIROLaser Blue are identical to the accessories cleared for use with the predicate device and therefore no new biocompatibility testing was performed to support substantial equivalence.
- . Validation of the device's software in conformity with IEC 62304 (Medical device software – Software lifecycle processes).
- Published bench test data is included which summarize studies conducted utilizing the . SIROLaser Blue device comparing the cutting efficiency of the 445 nm laser wavelength (through histological examination of cutting depth and tissue denaturation) with the 970 nm laser wavelength of the secondary predicate device (K103753).
Clinical Performance Data 8.
No human clinical data was included to support substantial equivalence.
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Conclusion Regarding Substantial Equivalence 9.
The information included in this premarket notification supports the substantial equivalence of the subject SIROLaser Blue. The subject device has the identical intended use as the legally marketed predicate device. The subject device also has the same indications for use and incorporates the same fundamental technology as the predicate devices.
Performance and biocompatibility data are included in this premarket notification to demonstrate the performance of the subject SIROLaser Blue against its design, functional, and safety requirements. The results of the testing included in this premarket notification support a determination of substantial equivalence.
§ 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.