(74 days)
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No
The summary describes a dental laser system and its clinical performance for treating aphthous ulcers. There is no mention of AI, ML, image processing, or any data-driven decision-making components. The performance studies focus on clinical outcomes of laser treatment, not algorithmic performance.
Yes
The "# Intended Use / Indications for Use" states "treatment of aphthous ulcers," which is a medical condition, and the "# Summary of Performance Studies" describes studies showing the device's effectiveness in treating these ulcers, indicating a therapeutic purpose.
No
The device is described as a Dental Laser System intended for the "treatment of aphthous ulcers" and the "control and relief of most aphthous lesions," which indicates a therapeutic rather than a diagnostic purpose.
No
The device is described as a "Dental Laser System," which is a hardware device that uses a laser for treatment. The summary also describes performance studies involving the application of a pulsed Nd: YAG laser.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "treatment of aphthous ulcers." This is a therapeutic purpose, not a diagnostic one.
- Device Description: The device is a "Dental Laser System." Lasers used for treatment are typically therapeutic devices, not diagnostic ones.
- Lack of Diagnostic Elements: The description does not mention any components or functions related to analyzing samples (like blood, urine, tissue), detecting biomarkers, or providing diagnostic information.
- Performance Studies: The performance studies focus on the therapeutic outcomes of the treatment (pain relief, healing time, recurrence) rather than diagnostic accuracy (sensitivity, specificity, etc.).
IVD devices are used to examine specimens derived from the human body to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease. This device's purpose is to directly treat a condition, not to provide diagnostic information.
N/A
Intended Use / Indications for Use
The use of the PulseMaster laser for treatment of aphthous ulcers is substantially equivalent to the use of the PulseMaster laser for coagulation of other intraoral soft tissue.
Product codes
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Device Description
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Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
intraoral soft tissue
Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies
Independent studies have been carried out using a pulsed Nd: Y AG laser to treat aphthous ulcers. In one study, 21 patients were treated, eight with recurrent aphthous ulcers and 14 with herpes labialis lesions. The patients were evaluated over a period ranging from six months to eighteen months and the patients were asked to keep a daily calendar over that time period. The study was begun with both treated lesions and untreated, control lesions in each patient. However, all lesions were treated before the end of the study. Results were based on both the investigator's evaluation at follow-ups and the patient's self evaluation. For those with aphthous ulcers, immediate relief of pain was reported in 63% of the patients, 50% reported faster healing, 50% had no recurrence within 6 months and 75% of the remaining group reported less severe recurrences. The authors concluded that the pulsed Nd: YAG laser treatment was effective in the control and relief of most aphthous lesions.
In another study using a pulsed Nd: YAG laser for treatment of recurrent aphthous ulcers, three case studies were presented. The patients reported no discomfort during the procedure and no postoperative discomfort or other problems. The patients reported immediate relief of the painful symptoms of the lesions. The authors' conclusion was that the laser treatment compared favorably with other treatments due to no side effects or contraindications, and immediate palliation of the lesions.
Key Metrics
Immediate relief of pain was reported in 63% of the patients, 50% reported faster healing, 50% had no recurrence within 6 months and 75% of the remaining group reported less severe recurrences.
Predicate Device(s)
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Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 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
90,1136
510(k) Summary
Device Name:
PulseMaster Trade Name: Common Name: Dental Laser System Surgical Laser System Classification Name: Aphthous Ulcers Indication for Use
Submitter:
American Dental Technologies, Inc. 125 Shoreway Road Suite 3000 San Carlos, CA 94070
Contact Person:
Michael Yessik Tel.: 415-595-7723 Fax: 415-595-3982
Date Prepared:
・、・
March 19, 1996
1
This 510(k) Premarket Notification is for a new indication for use for the legally marketed PulseMaster laser family. The use of the PulseMaster laser for treatment of aphthous ulcers is substantially equivalent to the use of the PulseMaster laser for coagulation of other intraoral soft tissue.
Independent studies have been carried out using a pulsed Nd: Y AG laser to treat aphthous ulcers. In one study, 21 patients were treated, eight with recurrent aphthous ulcers and 14 with herpes labialis lesions. The patients were evaluated over a period ranging from six months to eighteen months and the patients were asked to keep a daily calendar over that time period. The study was begun with both treated lesions and untreated, control lesions in each patient. However, all lesions were treated before the end of the study. Results were based on both the investigator's evaluation at follow-ups and the patient's self evaluation. For those with aphthous ulcers, immediate relief of pain was reported in 63% of the patients, 50% reported faster healing, 50% had no recurrence within 6 months and 75% of the remaining group reported less severe recurrences. The authors concluded that the pulsed Nd: YAG laser treatment was effective in the control and relief of most aphthous lesions.
In another study using a pulsed Nd: YAG laser for treatment of recurrent aphthous ulcers, three case studies were presented. The patients reported no discomfort during the procedure and no postoperative discomfort or other problems. The patients reported immediate relief of the painful symptoms of the lesions. The authors' conclusion was that the laser treatment compared favorably with other treatments due to no side effects or contraindications, and immediate palliation of the lesions.
The results of these studies allow the following conclusions:
The use of the PulseMaster laser for treatment of aphthous ulcers is substantially equivalent to the use of the PulseMaster laser for ablation and coagulation of other intraoral soft tissues.
There are no new safety risks for this laser procedure.
The laser treatment for recurrent aphthous ulcers is equivalent to the standard of care for treatment of recurrent aphthous ulcers in terms of effectiveness.