(218 days)
The Sterling Diode Laser is indicated for: Dental soft tissue indications:
Dental, oral and soft tissue surgery including:
Sulcular debridement of diseased or fibrous tisue, excision and biopsy, gingivectory and gingivoplasty, lesion (tumor) removal, fibroma removal, tissue retraction (troughing), aphthous ulcers, gingival hyperplasia (excision and recontour), crown lengthening, operculectomy, frenectomy, and photocoagulation.
Laser periodontal procedures, including:
Laser soft tissue curettage; laser removal of diseased, infected and necrosed soft tissue within the periodontal pocket; removal of highly inflamed edematous tissue affected by bacteria penetration of the pocket lining and junctional epithelium.
The Sterling Diode Laser is a device for delivering laser energy to human soft tissue for a variety of surgical procedures and treatments. This energy is generated by solid-state diodes, which provide a consistent and reliable generation of laser energy at 810 ± 10nm for a maximum of 5 watts of energy is delivered to the surgical site by means of an optical fiber system, which allows for the safe transmission of laser energy to the site without creating undue risk to the patient or operatory staff by errant or collateral laser emissions. The target tissues absorb the laser energy converting it to heat. depending on the intensity or power output of the laser, the heat so generated can cell hemostasis, ablation, or vaporization. The device features some user definable settings, including a selectable 630nm aiming beam, adjustable power output for both the working beam and aiming beam, and continuous delivery or pulse delivery options.
The optical fiber is stored within the device and dispensed to the desired length according to the clinician's need. A fiber is passed through a reusable, sterilizeable handpiece assembly and terminated with a single-use disposable tip. The operator uses the handpiece to position and direct the laser energy to the intended treatment site. The activation of the working beam diodes is accomplished by use of a foot-actuated switch.
The provided document is a 510(k) premarket notification for the Sterling Diode Laser, seeking substantial equivalence to a predicate device. This type of regulatory submission focuses on comparing a new device to an existing legally marketed one, rather than presenting a detailed study proving the device meets specific performance acceptance criteria in the manner described for an AI/ML medical device.
Therefore, the information requested, which is typically relevant to AI/ML device studies, cannot be fully extracted or is not applicable to this document.
However, I can provide the available information that aligns with your request categories:
1. A table of acceptance criteria and the reported device performance:
The document doesn't explicitly define "acceptance criteria" in the sense of quantitative performance metrics for a study to prove the device meets them. Instead, it demonstrates substantial equivalence to a predicate device by comparing technical specifications and performance characteristics.
| Criterion Type | CAO Group, Inc. Sterling Diode Laser Performance | Ivoclar Vivadent, Inc. Odyssey 2.4G Predicate Performance |
|---|---|---|
| Working Beam Wavelength | $810 \pm 10$ nm | $810 \pm 20$ nm |
| Working Beam Output Power | 0.5 - 5.0 watts | 0.1 - 5.0 watts |
| Aiming Beam Output Power | < 3mW | < 3mW |
| Aiming Beam Wavelength | 630-650 nm | 630-650 nm |
| Laser Source | AlGaAs Diode | AlGaAs Diode |
| Laser Activation | Wireless foot pedal | Wireless foot pedal |
| Pulse Control | Digital emission control, Fixed pulse duration of 0.05 seconds, 10Hz | Digital emission control, Fixed pulse duration of 0.05 seconds, 10Hz |
| Cooling Method | Heatsink / Fan air cooled | Heatsink / Fan air cooled |
| Electrical Power Input | 100-240 VAC @ 47-63 Hz, 1.5A (switchable) | 100-240 VAC @ 47-63 Hz, 1.6A (switchable) |
| User Interface | Illuminated LED Display; Membrane keypad | Illuminated LED Display; Membrane keypad |
| Laser Delivery System | Quartz optical fiber | Quartz optical fiber |
| Dimensions | 9" x 6" x 5" | 10" x 8" x 4" |
| Weight | 5.0 lbs | 6.5 lbs (Control unit only) |
| Indications for Use | Identical to predicate device | Dental soft tissue and laser periodontal procedures |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document mentions "Bench testing on an evaluation sample of the submitted device was performed consistent with internal requirements" but does not specify the sample size of devices tested or the data provenance. This is not a clinical study involving human data, but rather performance testing of the device itself.
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. The ground truth in this context is the physical and electrical performance of the device, measured against engineering specifications and compared to a predicate device, not against expert interpretations of medical data.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. This is a technical performance comparison between two laser devices, not an assessment of diagnostic accuracy requiring adjudication.
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 document is for a medical laser device, not an AI/ML diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. This device is a physical laser system, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for this submission are the engineering specifications and measured performance characteristics of the Sterling Diode Laser, compared against the known specifications and performance of the legally marketed predicate device (Odyssey 2.4G Diode Laser) and relevant IEC/ANSI standards. This is a technical ground truth, not a medical one in the AI/ML sense.
8. The sample size for the training set
Not applicable. This is a hardware device, not an AI/ML algorithm requiring a training set.
9. How the ground truth for the training set was established
Not applicable. Again, this is a hardware device.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features the department's name in a circular arrangement around a stylized eagle symbol. The eagle is depicted with three profiles facing right, representing the department's focus on health and human well-being. The text reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA".
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
September 21, 2016
CAO Group, Inc. Mr. Robert K. Larsen Regulatory Affairs Manager 4628 West Skyhawk Drive West Jordan, UT 84084
Re: K160413
Trade/Device Name: Sterling 5W Diode Laser Regulation Number: 21 CFR 878.4810 Regulation Name: Laser surgical instrument for use in general and plastic surgery and in dermatology Regulatory Class: Class II Product Code: GEX Dated: August 22, 2016 Received: August 24, 2016
Dear Mr. Larsen:
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 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
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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 (reporting of medical device-related adverse events) (21 CFR Part 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours.
Christopher J. Ronk -S
Fox 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) K160413
Device Name Sterling Diode Laser
Indications for Use (Describe) The Sterling Diode Laser is indicated for: Dental soft tissue indications:
Dental, oral and soft tissue surgery including:
Sulcular debridement of diseased or fibrous tisue, excision and biopsy, gingivectory and gingivoplasty, lesion (tumor) removal, fibroma removal, tissue retraction (troughing), aphthous ulcers, gingival hyperplasia (excision and recontour), crown lengthening, operculectomy, frenectomy, and photocoagulation.
Laser periodontal procedures, including:
Laser soft tissue curettage; laser removal of diseased, infected and necrosed soft tissue within the periodontal pocket; removal of highly inflamed edematous tissue affected by bacteria penetration of the pocket lining and junctional epithelium.
| 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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Image /page/3/Picture/0 description: The image shows the logo for CAO GROUP, INC. The logo consists of a red square with a white Chinese character inside, followed by the text "CAO GROUP, INC." in black. Below the company name is the tagline "Easier · Faster · Better" in a smaller font.
4628 W. Skyhawk Drive
West Jordan, UT 84084
www.caogroup.com
301.256.9282 [phone]
877.877.9778 [toll free]
301.256.9287 [fax]
510(k) Summary
Prepared By: Robert K. Larsen Preparation Date: August 22, 2016
Device Name:
| Trade Name: | Sterling Diode Laser |
|---|---|
| Common Name: | Soft Tissue Diode Laser |
| Product Code: | GEX |
| Regulation: | 878.4810 |
| Product Classification: | Powered Laser Surgical InstrumentClass II |
Legally Marketed Predicate Devices for Substantial Equivalence:
Odyssey 2.4G Diode Laser, manufactured for Ivoclar Vivadent, Inc. (K050453)
Rationale for Substantial Equivalence:
The submitted device and identified predicate device share exactly identical indications for use: Dental soft tissue indications:
Dental, oral and soft tissue surgery including:
Sulcular debridement of diseased or fibrous tissue, excision and biopsy, gingivectorny and gingivoplasty, lesion (tumor) removal, fibroma removal, tissue retraction (troughing), aphthous ulcers, gingival hyperplasia (excision and recontour), crown lengthening, operculectomy, frenectomy, and photocoagulation.
Laser periodontal procedures, including:
Laser soft tissue curettage; laser removal of diseased, infected and necrosed soft tissue within the periodontal pocket; removal of highly inflamed edematous tissue affected by bacteria penetration of the pocket lining and junctional epithelium.
Description of Submitted Device:
The Sterling Diode Laser is a device for delivering laser energy to human soft tissue for a variety of surgical procedures and treatments. This energy is generated by solid-state diodes, which provide a consistent and reliable generation of laser energy at 810 ± 10nm for a maximum of 5 watts of energy is delivered to the surgical site by means of an optical fiber system, which allows for the safe transmission of laser energy to the site without creating undue risk to the patient or operatory staff by errant or collateral laser emissions. The target tissues absorb the laser energy converting it to heat. depending on the intensity or power output of the laser, the heat so generated can cell hemostasis, ablation, or vaporization. The device features
Page 1 of 4
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Image /page/4/Picture/0 description: The image is a logo for CAO GROUP, INC. The logo features a red square with a white Chinese character inside on the left. To the right of the square is the text "CAO GROUP, INC." in black, with a thin red line underneath. Below that, in a smaller font, is the text "E a s i e r . F a s t e r . B e t t e r" with a trademark symbol.
4628 W Skyhowk Drive West Jordan, UT 84084 www.caogroup.com
some user definable settings, including a selectable 630nm aiming beam, adjustable power output for both the working beam and aiming beam, and continuous delivery or pulse delivery options.
The optical fiber is stored within the device and dispensed to the desired length according to the clinician's need. A fiber is passed through a reusable, sterilizeable handpiece assembly and terminated with a single-use disposable tip. The operator uses the handpiece to position and direct the laser energy to the intended treatment site. The activation of the working beam diodes is accomplished by use of a foot-actuated switch.
Description of the Predicate Device:
The Odyssey 2.4G Diode Laser is a device for delivering laser energy to human soft tissue for a variety of surgical procedures and treatments. This energy is generated by solid-state diodes, which provide a consistent and reliable generation of laser energy at 810 ± 20nm for a maximum of 5 watts of energy output. The laser energy is delivered to the surgical site by means of an optical fiber system, which allows for the safe transmission of laser energy to the site without creating undue risk to the patient or operatory staff by errant or collateral laser emissions. The target tissues absorb the laser energy converting it to heat. depending on the intensity or power output of the laser, the heat so generated can cell hemostasis, ablation, or vaporization. The device features some user definable settings, including a selectable 630nm aiming beam, adjustable power output for both the working beam and aiming beam, and continuous delivery or pulse delivery options.
The optical fiber is stored within the device and dispensed to the desired length according to the clinician's need. A fiber is passed through a reusable, sterilizeable handpiece assembly and terminated with a single-use disposable tip. The operator uses the handpiece to position and direct the laser energy to the intended treatment site. The activation of the working beam diodes is accomplished by use of a foot-actuated switch.
Indications for Use of the Submitted Device:
The submitted device is indicated for use for -Dental soft tissue indications:
Dental, oral and soft tissue surgery including:
Sulcular debridement of diseased or fibrous tissue, excision and biopsy, gingivectomy and gingivoplasty, lesion (tumor) removal, fibroma removal, tissue retraction (troughing), aphthous ulcers, gingival hyperplasia (excision and recontour), crown lengthening, operculectomy, frenectomy, and photocoagulation.
Laser periodontal procedures, including:
Laser soft tissue curettage; laser removal of diseased, infected and necrosed soft tissue within the periodontal pocket; removal of highly inflamed edematous tissue affected by bacteria penetration of the pocket lining and junctional epithelium.
| Technological Characteristics and Substantial Equivalence: | ||
|---|---|---|
| CAO Group, Inc. Sterling Diode Laser | Ivoclar Vivadent, Inc. Odyssey 2.4G | |
| WorkingBeam OutputPower | $810\pm10$ nm | $810\pm20$ nm |
| CAO Group, Inc. Sterling Diode Laser | Ivoclar Vivadent, Inc. Odyssey 2.4G | |
| WorkingBeam OutputWavelength | 0.5 - 5.0 watts | 0.1 - 5.0 watts |
| Aiming BeamOutput Power | < 3mW | < 3mW |
| Aiming BeamOutputWavelength | 630-650 nm | 630-650 nm |
| Laser Source | AlGaAs Diode | AlGaAs Diode |
| LaserActivation | Wireless foot pedal | Wireless foot pedal |
| Pulse Control | Digital emission controlFixed pulse duration of 0.05 seconds, 10Hz | Digital emission controlFixed pulse duration of 0.05 seconds, 10Hz |
| CoolingMethod | Heatsink / Fan air cooled | Heatsink / Fan air cooled |
| ElectricalPower Input(System) | 100-240 VAC @ 47-63 Hz, 1.5A (switchable) | 100-240 VAC @ 47-63 Hz, 1.6A (switchable) |
| User Interface | Illuminated LED Display;Membrane keypad | Illuminated LED Display;Membrane keypad |
| Laser DeliverySystem | Quartz optical fiber | Quartz optical fiber |
| Dimensions | 9" x 6" x 5" | 10" x 8" x 4" |
| Weight | 5.0 lbs | 6.5 lbs (Control unit only) |
| 510(k)Number | Pending this application. | K050453 |
| Indicationsfor Use | Dental soft tissue indications:Dental, oral and soft tissue surgery including:Sulcular debridement of diseased or fibroustissue, excision and biopsy, gingivectomy andgingivoplasty, lesion (tumor) removal, fibromaremoval, tissue retraction (troughing),aphthous ulcers, gingival hyperplasia (excisionand recontour), crown lengthening,operculectomy, frenectomy, andphotocoagulation.Laser periodontal procedures, including:Laser soft tissue curettage; laser removal ofdiseased, infected and necrosed soft tissuewithin the periodontal pocket; removal ofhighly inflamed edematous tissue affected by | Dental soft tissue indications:Dental, oral and soft tissue surgery including:Sulcular debridement of diseased or fibroustissue, excision and biopsy, gingivectomy andgingivoplasty, lesion (tumor) removal, fibromaremoval, tissue retraction (troughing),aphthous ulcers, gingival hyperplasia (excisionand recontour), crown lengthening,operculectomy, frenectomy, andphotocoagulation.Laser periodontal procedures, including:Laser soft tissue curettage; laser removal ofdiseased, infected and necrosed soft tissuewithin the periodontal pocket; removal ofhighly inflamed edematous tissue affected by |
Page 2 of 4
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Image /page/5/Picture/0 description: The image shows the logo for CAO GROUP, INC. The logo consists of a red square with a white Chinese character inside, followed by the text "CAO GROUP, INC." in black. Below the text is the tagline "E a si e r · F a s t e r · B e t t e r™" in a smaller font.
4628 W. Skyhawk Drive 801.256.9282 [phone] West Jordan, UT 84084 877.877.9778 [toll free] www.caogroup.com 801.256.9287 [fax]
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Image /page/6/Picture/0 description: The image shows the logo for CAO Group, Inc. The logo consists of a red square with a white Chinese character inside, followed by the text "CAO GROUP, INC." in black. Below the company name, there is a tagline that reads "Easier · Faster · Better™".
| 4628 W. Skyhawk Drive | 801.256.9282 [phone] |
|---|---|
| West Jordan, UT 84084 | 877.877.9778 [toll free] |
| www.caogroup.com | 801.256.9287 [fax] |
| CAO Group, Inc. Sterling Diode Laser | Ivoclar Vivadent, Inc. Odyssey 2.4G |
|---|---|
| bacteria penetration of the pocket lining andjunctional epithelium. | bacteria penetration of the pocket lining andjunctional epithelium. |
Conformity to Standards:
The Sterling Diode Laser is designed to comply with the performance requirements of ANSJ/AAMI ES60601-1:2005, IEC 60601-1-2:2007, IEC 60601-1-6:2006, IEC 60601-2-22:2007, and IEC 60825-1:2007.
Performance Data:
Bench testing on an evaluation sample of the submitted device was performed consistent with internal requirements:
- QAC-P02265 - Final assembly inspection of Sterling Diode Laser
- . Sterling 5W Main and Safety Specification Verification Test
Conclusion:
The Sterling 5W Diode Laser is substantially equivalent to the listed predicate. This device shares identical intended uses, identical operating principles, similar design features, and identical functional and performance characteristics.
§ 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.