(147 days)
Not Found
No
The summary describes a laser system with a microprocessor for control, but there is no mention of AI, ML, image processing, or any data-driven algorithms typically associated with AI/ML in medical devices. The performance studies focus on laser characteristics and clinical outcomes compared to predicate devices and traditional methods.
Yes
The device is used for the selective ablation of enamel dental caries, which indicates a therapeutic purpose.
No
The device is described as a laser system for the selective ablation of dental caries, which is a treatment function, not a diagnostic one.
No
The device description explicitly states it consists of hardware components including a cabinet housing the laser head, power supply, cooling system, microprocessor, control panel, and a fiber optic delivery system.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to provide information for diagnosis, monitoring, or screening.
- Device Function: The description clearly states that the PulseMaster Dental Laser Systems are used for the "selective ablation of enamel (first degree) dental caries." This is a direct treatment or intervention performed on the patient's tooth, not a test performed on a sample taken from the patient.
- Lack of IVD Characteristics: The description does not mention any analysis of biological samples, detection of biomarkers, or diagnostic testing.
Therefore, the PulseMaster Dental Laser System is a therapeutic device used for dental treatment, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The American Dental Technologies, Inc. PulseMaster Dental Laser Systems are indicated for use for selective ablation of first degree enamel caries.
Product codes (comma separated list FDA assigned to the subject device)
GEX
Device Description
The American Dental Technologies PulseMaster Dental Laser Systems are Nd:YAG lasers producing laser emission at 1064 nm. The lasers consist of two interconnected sections: The cabinet which houses the laser head, the power supply, the cooling system and the microprocessor with control panel; and the fiber optic delivery system.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
enamel
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
An extracted tooth study was conducted to evaluate the histological effects of the laser treatment.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Bench test data were collected under controlled scientific conditions to establish the substantial equivalence of the PulseMaster Dental Laser Systems to a pulsed Er:YAG Dental Laser. We measured the temporal pulse structures and effects on enamel caries and found the two lasers to be equivalent. An extracted tooth study was conducted to evaluate the histological effects of the laser treatment. The histology indicated that the device is safe for the intended use. Clinical data from a multi-center, blinded, randomized study comparing the PulseMaster to the highspeed handpiece established the safety and effectiveness of the PulseMaster Dental Laser Systems for the Intended use.
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.
Not Found
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
K9844486
Attachment I 510(K) Summary American Dental Technologies PulseMaster Dental Laser Systems
This 510(K) Summary of safety and effectiveness for the American Dental Technologies Philo of of(x) Dammary of Submitted in accordance with the requirements of the SMDA 1990 and following guidance concerning the organization and content of a 510(K) summary.
| Applicant: | American Dental Technologies, Inc. |
|---|---|
| Address: | 18860 West Ten Mile Road |
| Southfield, MI 48075-2657 | |
| Contact Person: | John Sulewski |
| Telephone: | (248) 395-3900 - Phone |
| (248) 395-3801 – Fax | |
| Preparation Date: | 12-16-98 |
| Device Trade Name: | PulseMaster Dental Laser Systems |
| Common Name: | Nd:YAG Pulsed Laser |
| Classification Name: | Instrument, Surgical, Powered, Laser |
| 79-GEX | |
| 21 CFR 878-48 | |
| Legally Marketed Predicate Device: | The Centauri Dental Laser manufactured by Premier |
| Laser Systems, #3 Morgan Street, Irvine, CA , | |
| previously cleared for market under 510(k) number | |
| K932683. | |
| Description of the American Dental | |
| Technologies PulseMaster Dental | |
| Laser Systems | The American Dental Technologies PulseMaster Dental |
| Laser Systems are Nd:YAG lasers producing laser | |
| emission at 1064 nm. The lasers consist of two | |
| interconnected sections: The cabinet which houses | |
| the laser head, the power supply, the cooling system | |
| and the microprocessor with control panel; and the fiber | |
| optic delivery system. | |
| Intended use of the American Dental | |
| Technologies PulseMaster Dental | |
| Laser Systems | The American Dental Technologies, Inc. PulseMaster |
| Dental Laser Systems are indicated for use for selective | |
| ablation of first degree enamel caries. | |
| Nonclinical Performance Data: | Bench test data were collected under controlled |
| scientific conditions to establish the substantial | |
| equivalence of the PulseMaster Dental Laser Systems | |
| to a pulsed Er:YAG Dental Laser. We measured the | |
| temporal pulse structures and effects on enamel caries | |
| and found the two lasers to be equivalent. | |
| Clinical Performance Data: | An extracted tooth study was conducted to evaluate |
| the histological effects of the laser treatment. The | |
| histology indicated that the device is safe for the | |
| intended use. Clinical data from a multi-center, blinded, | |
| randomized study comparing the PulseMaster to the | |
| highspeed handpiece established the safety and | |
| effectiveness of the PulseMaster Dental Laser Systems | |
| for the Intended use. | |
| Conclusion: | The American Dental Technologies PulseMaster Dental |
| Laser Systems are substantially equivalent to another | |
| existing surgical laser system in commercial distribution | |
| for selective ablation of enamel caries and to | |
| commercially available High Speed Dental Handpieces. | |
| Additional Information: | None requested at this time |
1
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle with three stripes extending from its head, representing the department's mission to protect the health of all Americans and provide essential human services.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY 1 3 1999
Mr. John G. Sulewski Product Manager American Dental Technologies, Inc. 18860 West Ten Mile Road Southfield. Michigan 48075-2657
Re: K984486 Trade Name: PulseMaster Dental Laser Systems Regulatory Class: II Product Code: GEX Dated: March 15, 1999 Received: March 16, 1999
Dear Mr. Sulewski:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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.
If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (OS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
3
Page 2 - Mr. John G. Sulewski
This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4595. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Celia M. Witten, Ph.D., M.D.
Director
Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
INDICATION FOR USE STATEMENT
510(k) Number. K 984486 New Submission
Device Name: PulseMaster Dental Laser Systems
Indications for Use:
The American Dental Technologies, Inc. PulseMaster Dental Laser Systems are indicated for use for selective ablation of enamel (first degree) dental caries.
(Please do not write below this line - Continue on another page if needed)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of General Restorative Devices K984486
510(k) Number
Prescription Use
(per 21 CFR 801.109)
OR
Over-the-Counter Use__________________________________________________________________________________________________________________________________________________________