(282 days)
No
The device description focuses on the physical components and energy delivery mechanism of a diode laser, with no mention of AI or ML capabilities. The "Mentions AI, DNN, or ML" section explicitly states "Not Found".
Yes
The device is used for medical procedures such as removal of lesions, excision, incision, vaporization, ablation, hemostasis, and photocoagulation on oral soft tissue, which are all therapeutic interventions.
No
The device description clearly states its purpose is for "delivering laser energy to human soft tissue for a variety of surgical procedures and treatments," which are therapeutic interventions, not diagnostic ones.
No
The device description clearly outlines hardware components such as solid-state diodes, an optical fiber system, a metal handpiece with a disposable tip, and a foot-actuated switch, indicating it is a physical medical device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is for surgical procedures and treatments performed directly on oral soft tissue for various dental and oral surgery procedures. This involves interacting with the patient's body.
- Device Description: The description details a laser device that delivers energy to human soft tissue via an optical fiber. This is a therapeutic and surgical device, not a device used to examine specimens in vitro (outside the body).
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue samples, etc.) or providing diagnostic information based on such analysis. IVDs are used to diagnose diseases or conditions based on tests performed on these samples.
Therefore, the Precise SHP Diode Laser is a surgical/therapeutic device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Precise SHP Diode Laser is indicated for the removal of lesions, excision, incision, vaporization, ablation, hemostasis, and photocoagulation on oral soft tissue for the specific dental and oral surgery procedures of gingivectomy, operculectomy, contouring, biopsy, troughing, ulcer care, abscess care, sulcular debridement, soft tissue curettage, and removal of inflamed edematous tissue.
Product codes
GEX
Device Description
The Precise SHP 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 3 watts of energy output. The laser energy is delivered to 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 device features some user definable settings, including a switchable 630nm aiming beam, adjustable power output for both the working beam and aiming beam, and continuous delivery or pulse delivery options.
The working end of the delivery fiber is contained within a metal handpiece with a disposable single-use tip. This handpiece system is provided with the device. The activation of the working beam diodes is completed by use of a foot-actuated switch.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
oral soft tissue
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Bench testing on an evaluation sample of the current device revealed that the device met the design criteria for essential performance, and satisfied the performance requirements indicated in 21 CFR 1010 and 21 CFR 1040. Device outputs were within performance requirements and all safety features and functions were operating correctly.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
510(k) Summary of Safety and Effectiveness
CAO Group, Inc. 4628 West Skyhawk Drive West Jordan, UT 84084 Tel: 801-256-9282 Fax: 801-256-9287
Prepared By: Robert K. Larsen, Preparation Date: November 15, 2011
Device Name:
| Trade Name: | Precise SHP Diode Laser |
|---|---|
| Common Name: | Soft Tissue Diode Laser |
| Product Classification: | Powered Laser Surgical Instrument |
Legally Marketed Predicate Devices for Substantial Equivalence:
Odyssey Navigator Diode Laser, manufactured by Ivoclar Vivadent, Inc. (K062258)
DenLaser 800 Plus, manufactured by CAO Group, Inc. (K062619)
Rationale for Substantial Equivalence:
The aforementioned devices share similar indications for use with the present device for excision, incision, ablation, and photocoagulation on soft tissue for a variety of procedures in dentistry. The predicate devices and submitted device share similar design features including wavelength, operating controls, and laser delivery method. The devices share similar methods of control systems, safety features, and performance monitoring. The devices share similar performance specifications including power output and energy type.
Description of Submitted Device:
The Precise SHP 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 3 watts of energy output. The laser energy is delivered to 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 device features some user definable settings, including a switchable 630nm aiming beam,
1
adjustable power output for both the working beam and aiming beam, and continuous delivery or pulse delivery options.
The working end of the delivery fiber is contained within a metal handpiece with a disposable single-use tip. This handpiece system is provided with the device. The activation of the working beam diodes is completed by use of a foot-actuated switch.
Intended Uses of the Submitted Device:
The Precise SHP Diode Laser is indicated for the removal of lesions, excision, vaporization, ablation, hemostasis, and photocoagulation on oral soft tissue for the specific dental and oral surgery procedures of gingivectomy, operculectomy, contouring, biopsy, troughing, ulcer care, abscess care, sulcular debridement, soft tissue curettage, and removal of inflamed edematous tissue.
Technological Characteristics and Substantial Equivalence:
The Odyssey Navigator Diode Lasers uses solid state diodes to generate laser energy in the 810nm range. This system uses a fiber delivery system to transmit laser energy to the surgical site. The system also features a 630nm aiming beam and features controls that allow for adjusting the output of the working beam, and switching between a continuous or pulsed-mode laser emissions. The maximum output of the working beam is 3 watts.
The DenLaser 800 Plus uses solid state diodes to generate laser energy in the 810nm range. This system uses a fiber delivery system to transmit laser energy to the surgical site. The system also features a 630nm aiming beam and features controls that allow for adjusting the output of the working beam, and switching between a continuous or pulsed-mode laser emissions. The maximum output of the working beam is 5 watts.
Conformity to Standards:
The Precise SHP Diode Laser is designed to comply with the performance requirements . of 21 CFR 1040.10 and 1040.11, with permissible deviations relative to Laser Notice 50, dated June 24, 2007. The device also complies with the recognized standards of IEC 60601-2-22 Edition 3 and IEC 60825-1 Edition 2. The device also designed in compliance to the entirety of 1EC 60601-1: 3nd Edition, 1EC 60601-1-2, IEC 60601-1-4, and IEC 60601-1-6.
Performance Data
Bench testing on an evaluation sample of the current device revealed that the device met the design criteria for essential performance, and satisfied the performance requirements
2
indicated in 21 CFR 1010 and 21 CFR 1040. Device outputs were within performance requirements and all safety features and functions were operating correctly.
Conclusion
The Precise SHP Diode Laser is substantially equivalent to the listed predicate devices without raising any new issues of safety or effectiveness. This device shares similar intended uses, operating principles, design features, and similar functional and performance abaracteristics. The device is designed to comply with relevant federal and international safety and performance standards.
3
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle or bird-like figure with three curved lines representing its body and wings. The logo is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" in a circular arrangement.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
AUG 30 2012
CAO Group, Incorporated % Mr. Robert K. Larsen Regulatory Affairs Manager 4628 West Skyhawk Drive West Jordan, Utah 84084
Re: K113472
Trade/Device Name: Precise SHP 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 20, 2012 Received: August 22, 2012
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 that I Drines interes and regulations administered by other Federal agencies. You must
4
Page 2 - Mr. Robert K. Larsen
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 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 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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 Small Manufacturers, International and Consumer Assistance 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.
Sincerely yours,
FOR
Mark N. Melkerson
Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Indications for Use
510(k) Number (if known):
Device Name:
Indications For Use:
The Precise SHP Diode Laser is indicated for the removal of lesions, excision, incision, vaporization, ablation, hemostasis, and photocoagulation on oral soft tissue for the specific dental and oral surgery procedures of gingivectomy, freeectomy, operculectomy, contouring, biopsy, troughing, ulcer care, abscess care, sulcular debridement, soft tissue curettage, and removal of inflamed edematous tissue.
Prescription Use X (Per 21 CFR 801 Subpart D)
Over-The-Counter Use AND/OR (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Melh R. Sella Lis mkn
Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K113472
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