(260 days)
No
The device description details a microprocessor-controlled laser system with feedback loops for energy monitoring and adjustment, but it does not mention any AI or ML algorithms for decision-making, image processing, or other functions.
Yes
The device is intended for various dental and surgical procedures such as abscess incision and drainage, fibroma removal, gingivectomy, and sulcular debridement, all of which are considered therapeutic interventions for treating diseases or injuries.
No
This device is a surgical laser system intended for ablating, incising, vaporization, and coagulation of soft tissues, as well as for procedures like debridement and regeneration. It is used for treatment, not for diagnosing conditions.
No
The device description clearly outlines hardware components such as a laser head, flashlamp, fiber-optic cable, sensors, cooling system, and a touch screen display, indicating it is a physical medical device with integrated software for control.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a device used for surgical procedures on soft tissues within the mouth and other parts of the body. This involves direct interaction with the patient's tissues for therapeutic purposes (ablation, incision, vaporization, coagulation, etc.).
- Device Description: The device description details a laser system designed to deliver energy to tissue. It describes the laser head, fiber-optic delivery, cooling system, and controls, all consistent with a surgical laser.
- Lack of IVD Characteristics: An IVD device is used to examine specimens (like blood, urine, tissue samples) in vitro (outside the body) to provide information for diagnosis, monitoring, or screening. The provided information does not mention any analysis of biological samples or diagnostic testing.
- Performance Studies: The performance study described is a human histological study evaluating the outcome of a surgical procedure (periodontal regeneration) on treated teeth. This is a clinical study of a therapeutic intervention, not an IVD performance study.
In summary, the PerioLase Nd: YAG Pulsed Dental Laser System is a surgical device used for treating soft tissues, not a device used for in vitro diagnostic testing.
N/A
Intended Use / Indications for Use
The PerioLase Nd: YAG Pulsed Dental Laser System is to provide the ability to perform intraoral soft tissue dental, general, oral maxillofacial, and cosmetic surgery. The PerioLase is intended for ablating, incising, vaporization and coagulation of soft tissues using a contact fiber-optic delivery system. The following areas: general and cosmetic dentistry, otolary, arthroscopy, gastroenterology, general surgery, dermatology and plastic surgery, neurosurgery, gynecology, ophthalmology, and pulmonary general surgery. The following are the oropharyngeal indications for use for which the device will be marketed:
Oropharyngeal
- · Abscess incision and drainage
- · Aphthous ulcers treatment
- · Biopsies excision and incision
- · Crown lengthening
- · Hemostatic assistance
- Fibroma removal
- · Frenectomy
- · Frenotomy
- Gingival incision and excision
- · Gingivectomy
- Gingivoplasty
- · Operculectomy
- · Oral papillectomy
- · Tissue retraction for impression
- · Vestibuloplasty
- · Selective ablation of enamel (first degree) caries
- · Exposure of unerupted / partially erupted teeth
- · Implant recovery
- · Lesion (tumor) removal
- · Leukoplakia
- · Pulpotomy
- · Pulpotomy as adjunct to root canal therapy
- · Removal of filling material such as gutta-percha or resin as adjunct treatment during root canal retreatment
· Sulcular debridement (removal of diseased or in the periodontal pocket) to improve clinical indices including gingival index, gingival bleeding index, probe depth, attachment level and tooth mobility
· Laser-assisted new attachment procedure (cementum-mediated periodontal ligament to the root surface in the absence of long junctional epithelium)
· Periodontal regeneration of the attachment apparatus (new cementum, new periodontal ligament, and new alveolar bone) on a previously diseased root surface when used specifically in the LANAP® Protocol
Product codes
GEX
Device Description
The laser head consists of a flashlamp-pulsed Nd:YAG rod in an optical resonant cavity. The energy and the width of each laser pulse are determined by the size and shape of the current pulse through the flashlamp. The current pulse through the flashlamp is controlled by the flashlamp switching circuit. This circuit is based on a solid-state switch that sets the current level and pulse width according to the microprocessor controller. The rate at which the laser pulses are produced, the repetition rate or the pulses/second, is also determined by the microprocessorcontrolled switching circuit. The output energy of each laser pulse is measured by the internal energy monitor. This value is compared to the energy setting by the microcontroller and adjustments are made if necessary.
The laser beam emitted from the laser head is coupled into a fiber-optic cable at the fiber port. The presence of the fiber-optic cable is detected by a sensor such that the laser will not fire if the fiber-optic cable is not in place. The laser aperture is at the distal tip of the fiber. The laser head is cooled by circulating water whose excess heat is removed by an air-water heat exchanger.
The operator controls the laser through the touch screen display. The microcontroller handles all of the logic required to set the energy levels, pulse widths, and repetition rates for the laser output, monitors the output pulses to assure proper output energy, monitors all of the interlocks and sensors, and checks for proper operation of the switches, power supplies, and cooling system. Proper operation of the microcontroller is checked by an independent watchdog microprocessor. The system is designed such that no single fault can result in a system failure.
All of the requirements of the laser safety standards of the CDRH as well as of the IEC 60825-1 standard are incorporated, including the remote interlock connector, the laser stop button, the key control, and the safety and manufacturers labels.
| Wavelength | 1.064 microns (1064 nm) |
|---|---|
| Pulse Energy | 20 to 300 mJ |
| Pulse Width | 100 µsec to 650 µsec |
| Repetition Rate | 10 to 100 Hz |
| Average Power | 6 Watts maximum |
| Laser Classification | Class IV |
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
intraoral soft tissue, oropharyngeal, Periodontium (cementum, periodontal ligament, alveolar bone), gingiva, dentition (enamel, root surface)
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)
Clinical Performance Data:
Periodontitis is an infectious disease that progressively destroys the alveolar bone, the periodontal ligament, and the root cementum that attach the teeth to the bone. Destruction of this attachment apparatus results in the loss of teeth. The ultimate aim of periodontal regeneration techniques is to induce or guide healing to regenerate the morphology back to its original configuration. In order to evaluate a regeneration technique experimentally, a notch is made on the root surface at the bottom of a periodontal pocket to provide a histological landmark for the apical extent of the destruction. True periodontal regeneration is then defined by histological evidence of new bone, periodontal ligament, and cementum appearing above the notch on a previously diseased root surface.
Results of a prospective human histological study provide evidence of true periodontal regeneration with new cementum, periodontal ligament, and alveolar bone on previously diseased root surfaces in patients treated nine months earlier with the LANAP® protocol using the PerioLase Nd:YAG Pulsed Dental Laser System.
Eight patients treated with the LANAP® protocol using the PerioLase Nd:YAG laser provided twelve treated teeth that were scheduled for extraction. After nine months of healing, en bloc biopsy extractions were evaluated histologically to assess periodontal wound healing.
Two teeth splintered during histological preparation and were not available for microscopic evaluation. Four teeth healed via long junctional epithelium and one tooth demonstrated new cementum and reattachment apical to the notch.
Five of the remaining ten sites (50%) healed coronal to the notch with true periodontal regeneration, demonstrating new cementum, new periodontal ligament, and new alveolar bone with inserting Sharpey's fibers forming functional reattachments.
Three teeth demonstrating regeneration coronal to the notch also presented with loss of attachment within furcations. These areas demonstrated new bone, new ligament, and new cementum as well.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
Image /page/0/Picture/1 description: The image is a black and white logo for the Department of Health & Human Services - USA. The logo features a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the circumference. Inside the circle is a stylized image of three human profiles facing right, with flowing lines above them that resemble a bird in flight.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
March 15, 2016
Millennium Dental Technologies Inc. Dr. David Harris Chief Science Officer 10945 South Street Suite 104-A Cerritos, CA 90703
Re: K151763
Trade/Device Name: PerioLase Nd: YAG Pulsed Dental Laser System Regulation Number: 21 CFR 878.4810 Regulation Name: General and Plastic Surgery Regulatory Class: Class II Product Code: GEX Dated: February 12, 2016 Received: February 16, 2016
Dear Dr. Harris:
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 comply with all the Act's requirements, including, but not limited to: registration and listing (21
1
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 (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.
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/ResourcesforYou/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,
Jennifer R. Stevenson -A
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
2
Indications for Use
510(k) Number (if known) K151763
Device Name
PerioLase Nd:YAG Pulsed Dental Laser System
Indications for Use (Describe)
The PerioLase Nd: YAG Pulsed Dental Laser System is to provide the ability to perform intraoral soft tissue dental, general, oral maxillofacial, and cosmetic surgery. The PerioLase is intended for ablating, incising, vaporization and coagulation of soft tissues using a contact fiber-optic delivery system. The following areas: general and cosmetic dentistry, otolary, arthroscopy, gastroenterology, general surgery, dermatology and plastic surgery, neurosurgery, gynecology, ophthalmology, and pulmonary general surgery. The following are the oropharyngeal indications for use for which the device will be marketed:
Oropharyngeal
- · Abscess incision and drainage
- · Aphthous ulcers treatment
- · Biopsies excision and incision
- · Crown lengthening
- · Hemostatic assistance
- Fibroma removal
- · Frenectomy
- · Frenotomy
- Gingival incision and excision
- · Gingivectomy
- Gingivoplasty
- · Operculectomy
- · Oral papillectomy
- · Tissue retraction for impression
- · Vestibuloplasty
- · Selective ablation of enamel (first degree) caries
- · Exposure of unerupted / partially erupted teeth
- · Implant recovery
- · Lesion (tumor) removal
- · Leukoplakia
- · Pulpotomy
- · Pulpotomy as adjunct to root canal therapy
- · Removal of filling material such as gutta-percha or resin as adjunct treatment during root canal retreatment
· Sulcular debridement (removal of diseased or in the periodontal pocket) to improve clinical indices including gingival index, gingival bleeding index, probe depth, attachment level and tooth mobility
· Laser-assisted new attachment procedure (cementum-mediated periodontal ligament to the root surface in the absence of long junctional epithelium)
· Periodontal regeneration of the attachment apparatus (new cementum, new periodontal ligament, and new alveolar bone) on a previously diseased root surface when used specifically in the LANAP® Protocol
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)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
3
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4
Image /page/4/Picture/0 description: The image shows the logo for Millennium Dental Technologies, Inc. The logo features a red geometric shape on the left, followed by the company name in blue, bold, capitalized letters. The geometric shape consists of three triangles stacked on top of each other. The company name is followed by the abbreviation "INC."
510(k) Summary
Submitter: Millennium Dental Technologies, Inc. 10945 South Street Suite 306 Cerritos, California 90703 Telephone: (562) 860-2906 Fax: (562) 860-2949 Contact Person: David Harris, Chief Science Officer Mobile: (510) 502-3345 Date Prepared: June 22, 2015 Date Revised: March 14, 2016
-
- Device Name:
| Trade Name: | PerioLase Nd:YAG Pulsed Dental Laser System |
|---|---|
| Common Name: | Nd:YAG Pulsed Dental Laser |
| Classification Name: | Laser surgical instrument for use in general and plastic |
| surgery and in dermatology | |
| Classification Regulation: | 21 CFR 878.4810 |
| Classification Panel: | General and Plastic Surgery |
| Device Class: | Class II |
| Product Code: | GEX |
2. Legally Marketed Predicate Device:
PerioLase, Millennium Dental Technologies, K030290
3. Device Description:
PerioLase Nd:YAG Pulsed Dental Laser System (same as K010771, K014272, and K030290)
The laser head consists of a flashlamp-pulsed Nd:YAG rod in an optical resonant cavity. The energy and the width of each laser pulse are determined by the size and shape of the current pulse through the flashlamp. The current pulse through the flashlamp is controlled by the flashlamp switching circuit. This circuit is based on a solid-state switch that sets the current level and pulse width according to the microprocessor controller. The rate at which the laser pulses are produced, the repetition rate or the pulses/second, is also determined by the microprocessorcontrolled switching circuit. The output energy of each laser pulse is measured by
5
the internal energy monitor. This value is compared to the energy setting by the microcontroller and adjustments are made if necessary.
The laser beam emitted from the laser head is coupled into a fiber-optic cable at the fiber port. The presence of the fiber-optic cable is detected by a sensor such that the laser will not fire if the fiber-optic cable is not in place. The laser aperture is at the distal tip of the fiber. The laser head is cooled by circulating water whose excess heat is removed by an air-water heat exchanger.
The operator controls the laser through the touch screen display. The microcontroller handles all of the logic required to set the energy levels, pulse widths, and repetition rates for the laser output, monitors the output pulses to assure proper output energy, monitors all of the interlocks and sensors, and checks for proper operation of the switches, power supplies, and cooling system. Proper operation of the microcontroller is checked by an independent watchdog microprocessor. The system is designed such that no single fault can result in a system failure.
All of the requirements of the laser safety standards of the CDRH as well as of the IEC 60825-1 standard are incorporated, including the remote interlock connector, the laser stop button, the key control, and the safety and manufacturers labels.
| Wavelength | 1.064 microns (1064 nm) |
|---|---|
| Pulse Energy | 20 to 300 mJ |
| Pulse Width | 100 µsec to 650 µsec |
| Repetition Rate | 10 to 100 Hz |
| Average Power | 6 Watts maximum |
| Laser Classification | Class IV |
4. Intended Uses:
The PerioLase Nd:YAG Pulsed Dental Laser System is to provide the ability to perform intraoral soft tissue dental, general, oral maxillofacial, and cosmetic surgery. The PerioLase is intended for ablating, incising, excising, vaporization and coagulation of soft tissues using a contact fiber-optic delivery system. The device will be used in the following areas: general and cosmetic dentistry, otolaryngology, arthroscopy, gastroenterology, general surgery, dermatology and plastic surgery, neurosurgery, gynecology, urology, ophthalmology, and pulmonary surgery. The following are the oropharyngeal indications for use for which the device will be marketed:
Oropharyngeal
- Abscess incision and drainage .
- Aphthous ulcers treatment .
- Biopsies excision and incision .
- Crown lengthening .
- Hemostatic assistance .
- Fibroma removal .
6
- Frenectomy .
- Frenotomy .
- Gingival incision and excision .
- Gingivectomy .
- Gingivoplastv .
- . Operculectomy
- Oral papillectomy .
- Tissue retraction for impression .
- Vestibuloplasty .
- Selective ablation of enamel (first degree) caries .
- Exposure of unerupted / partially erupted teeth .
- Implant recovery .
- Lesion (tumor) removal .
- Leukoplakia .
- Pulpotomv .
- Pulpotomy as adjunct to root canal therapy .
- Removal of filling material such as gutta-percha or resin as adjunct treatment . during root canal retreatment
- Sulcular debridement (removal of diseased or inflamed soft tissue in the . periodontal pocket) to improve clinical indices including gingival index, gingival bleeding index, probe depth, attachment level, and tooth mobility
- . Laser-assisted new attachment procedure (cementum-mediated periodontal ligament new-attachment to the root surface in the absence of long junctional epithelium)
- Promotion of true regeneration of the attachment apparatus (new cementum, . new periodontal ligament, and new alveolar bone) on a previously diseased root surface when used specifically in the LANAP® Protocol
5. Summary of a Comparison of Technological Characteristics:
The comparison table provided in the Substantial Equivalence Comparison section of this submission establishes the basis for the determination of substantial equivalence of the PerioLase Nd:YAG Pulsed Dental Laser System to its named predicate device.
The PerioLase Nd:YAG Pulsed Dental Laser System has the identical wavelength, laser medium, beam delivery system type (optical fiber), laser activation method (footswitch), power source (conventional AC power), type of aiming beam and cooling system, and intended uses as its named predicate device.
The PerioLase Nd:YAG Pulsed Dental Laser System's power, pulse duration, energy per pulse, and repetition rate are identical to its named predicate device. There are no differences between the subject and predicate with respect to technology.
6. Nonclinical Performance Data:
The PerioLase Nd:YAG Pulsed Dental Laser System has been evaluated via verification and validation tests and inspections for conformance to applicable regulations and safety standards. Each PerioLase is tested for electrical safety and output characteristics to ensure it meets the design criteria for essential performance, its safety features and functions operate correctly, and it satisfies the performance requirements specified in 21 CFR 1010 and 21 CFR 1040.
7
Representative data is presented in the Performance section and accompanying appendix of this submission.
7. Clinical Performance Data:
Periodontitis is an infectious disease that progressively destroys the alveolar bone, the periodontal ligament, and the root cementum that attach the teeth to the bone. Destruction of this attachment apparatus results in the loss of teeth. The ultimate aim of periodontal regeneration techniques is to induce or guide healing to regenerate the morphology back to its original configuration. In order to evaluate a regeneration technique experimentally, a notch is made on the root surface at the bottom of a periodontal pocket to provide a histological landmark for the apical extent of the destruction. True periodontal regeneration is then defined by histological evidence of new bone, periodontal ligament, and cementum appearing above the notch on a previously diseased root surface.
Results of a prospective human histological study provide evidence of true periodontal regeneration with new cementum, periodontal ligament, and alveolar bone on previously diseased root surfaces in patients treated nine months earlier with the LANAP® protocol using the PerioLase Nd:YAG Pulsed Dental Laser System.
Eight patients treated with the LANAP® protocol using the PerioLase Nd:YAG laser provided twelve treated teeth that were scheduled for extraction. After nine months of healing, en bloc biopsy extractions were evaluated histologically to assess periodontal wound healing.
Two teeth splintered during histological preparation and were not available for microscopic evaluation. Four teeth healed via long junctional epithelium and one tooth demonstrated new cementum and reattachment apical to the notch.
Five of the remaining ten sites (50%) healed coronal to the notch with true periodontal regeneration, demonstrating new cementum, new periodontal ligament, and new alveolar bone with inserting Sharpey's fibers forming functional reattachments.
Three teeth demonstrating regeneration coronal to the notch also presented with loss of attachment within furcations. These areas demonstrated new bone, new ligament, and new cementum as well.
8. Conclusions:
The PerioLase Nd:YAG Pulsed Dental Laser System is substantially equivalent to the predicate device in technical characteristics, design features, operating principles, functional and performance characteristics, and for the intended uses in the stated medical specialties. The PerioLase is designed to comply with applicable federal and international safety and performance standards. Histologic data support the new clinical outcome claim. There are no new safety and effectiveness issues.