(88 days)
No
The document describes a laser system for soft tissue procedures and mentions software control, but there is no indication of AI or ML technology being used for decision-making, image processing, or any other function.
Yes
The device is intended for various medical procedures such as lesion removal, biopsies, and sulcular debridement, which directly treat health conditions.
No
The device is described as an instrument for ablating, incising, excising, and coagulating intraoral soft tissue, indicating its purpose is for treatment and surgical procedures, not diagnosis. While it can be used for biopsies, a biopsy itself is a procedure to obtain a sample, which is then typically analyzed diagnostically by other means. The device itself does not provide diagnostic information.
No
The device description explicitly states it is a "portable diode laser system" and utilizes "high brightness diode laser technology," indicating it is a hardware device with software control, not a software-only device.
Based on the provided information, the PulseMaster® 1000 ST Dental Laser System is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use clearly describes a device used for surgical procedures on intraoral soft tissue (ablating, incising, excising, and coagulating). This is a direct treatment application on a living patient.
- Device Description: The description reinforces its function as a surgical laser system for tissue manipulation.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body to provide information for diagnosis, monitoring, or compatibility testing. IVD devices typically analyze samples like blood, urine, tissue biopsies, etc.
The device is a therapeutic device used for direct intervention on a patient's tissue.
N/A
Intended Use / Indications for Use
The PulseMaster® 1000 ST Dental Laser System is a portable instrument intended for ablating, incising, excising, and coagulating intraoral soft tissue (including the marginal and interdental gingiva) using a contact fiber optic delivery system. The device is indicated for use in the following procedures:
- lesion (tumor) removal
- biopsies
- fibroma removal
- frenectomies and frenotomies
- gingivoplasties
- gingivectomies
- leukoplakia
- operculectomies
- oral papillectomies
- aphthous ulcers
- 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 loss, and tooth mobility.
Product codes
GEX
Device Description
The PulseMaster® 1000 ST Dental Laser System is a portable diode laser system intended for ablating, incising, excising, and coagulating intraoral soft tissue (including the marginal and interdental gingiva) using a contact fiber optic delivery system. The device is software-controlled and utilizes high brightness diode laser technology to provide similar performance characteristics to Nd:YAG lasers.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
intraoral soft tissue (including the marginal and interdental gingiva), periodontal pocket
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)
Testing conducted on the PulseMaster® 1000 ST Dental Laser System includes software verification and validation, and conformance to all relevant requirements of the IEC 601 series of electrical standards.
An in vitro study compared the performance of the PulseMaster® 1000 Nd:YAG System to a diode laser system with output parameters identical to those of the PulseMaster® 1000 ST System. Comparison of width and depth of tissue removed, lateral and deep thermal coagulation, and temperature rise in underlying tissue showed that the performance of the diode laser system was the same or slightly better than that of the Nd:YAG system. No detrimental effects due to temperature or coagulation would be expected for either system during typical clinical usage for oral soft tissue applications.
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
SEP 1 9 1997
510(k) Summary
for
PulseMaster® 1000 ST Dental Laser System
SPONSOR INFORMATION 1.
American Dental Technologies, Inc. 28411 Northwestern Highway Southfield, MI 48034
Mr. John G. Sulewski Contact: 248-353-5300 Telephone:
Date Prepared: June 20, 1997
2. DEVICE NAME
| Proprietary Name: | PulseMaster® 1000 ST Dental Laser System |
|---|---|
| Common/Usual Name: | Dental Laser System |
| Classification Name: | Laser Surgical Instrument |
| Classification Status: | Class II |
PREDICATE DEVICES 3.
- PulseMaster® 1000 Dental Laser System . American Dental Technologies, Inc. K922901
- Aurora™ Diode Laser System . Premier Laser Systems, Inc. K954316
DEVICE DESCRIPTION AND INTENDED USE 4.
The PulseMaster® 1000 ST Dental Laser System is a portable diode laser system intended for ablating, incising, excising, and coagulating intraoral soft tissue
1
(including the marginal and interdental gingiva) using a contact fiber optic delivery system. The device is software-controlled and utilizes high brightness diode laser technology to provide similar performance characteristics to Nd:YAG lasers.
TECHNOLOGICAL CHARACTERISTICS 5.
The PulseMaster® 1000 ST Dental Laser System is similar in design, function, and intended use to the predicate surgical dental laser systems identified above. The Aurora System is also a diode laser which operates in a continuous or pulsed (gated) mode with similar wavelength range to the PulseMaster® 1000 ST. All three devices are software-controlled, utilize the same type of generic fiber optic delivery system, and have similar performance characteristics with respect to tissue effects.
6. DEVICE TESTING
Testing conducted on the PulseMaster® 1000 ST Dental Laser System includes software verification and validation, and conformance to all relevant requirements of the IEC 601 series of electrical standards.
An in vitro study compared the performance of the PulseMaster® 1000 Nd: YAG System to a diode laser system with output parameters identical to those of the PulseMaster® 1000 ST System. Comparison of width and depth of tissue removed, lateral and deep thermal coagulation, and temperature rise in underlying tissue showed that the performance of the diode laser system was the same or slightly better than that of the Nd: YAG system. No detrimental effects due to temperature or coagulation would be expected for either system during typical clinical usage for oral soft tissue applications.
2
Image /page/2/Picture/1 description: The image is a black and white logo for the Department of Health & Human Services - USA. The logo features a stylized abstract symbol resembling an eagle or bird in flight. The symbol is positioned to the right of the text, which is arranged in a circular pattern around the symbol. The text reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA".
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20856
Mr. John G. Sulewski .Product Manager American Dental Technologies 28411 Northwestern Highway Southfield, Michigan 48034
SEP 1 9 1997
Re: K972325
Trade Name: PulseMaster® 1000 ST Dental Laser System Regulatory Class: II Product Code: GEX Dated: June 20, 1997 Received: June 23, 1997
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 requirements , as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) 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,
ia 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
510(k) Number (if known): _ K 972321
PulseMaster® 1000 ST Dental Laser System Device Name: _
Indications For Use:
The PulseMaster® 1000 ST Dental Laser System is a portable instrument intended for ablating, incising, excising, and coagulating intraoral soft tissue (including the marginal and interdental gingiva) using a contact fiber optic delivery system. The device is indicated for use in the following procedures:
- lesion (tumor) removal ●
- biopsies ●
- fibroma removal ●
- frenectomies and frenotomies ●
- gingivoplasties
- gingivectomies ◆
- leukoplakia .
- . operculectomies
- . oral papillectomies
- . aphthous ulcers
- 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 loss, and tooth mobility.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NECESSARY)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of General Restorative Devices Kq 72325
510(k) Number
Prescription Use _
(Per 21 CFR 801.109)
OR
Over-The-Counter Use _