(87 days)
No
The description focuses on the physical components and laser parameters, with no mention of AI, ML, or image processing.
Yes
Explanation: The device is intended for medical purposes such as removing caries, preparing cavities, modifying enamel and dentin, and performing incision, excision, ablation, vaporization, and coagulation of soft tissue. These actions are therapeutic interventions.
No
The "Intended Use / Indications for Use" section describes the device's function as removing caries, preparing cavities, modifying enamel and dentin, and performing incision, excision, ablation, vaporization, and coagulation of soft tissue. These are all therapeutic or preparatory functions, not diagnostic ones. There is no mention of the device being used to identify or analyze a condition.
No
The device description explicitly details hardware components including a power supply, water cooling system, Er.YAG pump cavity and resonator assembly, 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 medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health. These tests are performed outside of the body (in vitro).
- PulseMaster Erbium Dental Laser System Function: The description clearly states the device is a laser system used for procedures performed directly on the patient's teeth and soft tissues (removal of caries, cavity preparation, incision, excision, etc.). These are therapeutic and surgical procedures, not diagnostic tests performed on samples.
The intended use and device description align with a therapeutic medical device used for dental and oral surgery, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The PulseMaster Erbium Dental laser System is intended for the removal of caries and cavity preparation for primary and secondary teeth, the modification and etching of enamel and dentin prior to acid etching, and the incision, excision, ablation, vaporization, and coagulation of soft tissue in oral and maxillofacial surgery including, but not limited to, gingival tissues.
Product codes
GEX, MXF
Device Description
The PulseMaster Erbium Dental Laser System is a solid state Er.YAG laser consisting of three internally connected subassemblies: the power supply, the water cooling system, and the Er. YAG pump cavity and resonator assembly. Delivery is via a fiber optic with a sapphire contact tip. The laser delivers up to 400 mJ per pulse, with pulse repetition rates ranging from 10 to 60 Hz and an average power of up to 7.5 Watts.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
oral and maxillofacial
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)
Not Found
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 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
012127 1/2
OCT - 4 2001
510(k) Summary
for
PulseMaster Erbium Dental Laser System
SPONSOR 1.
American Dental Technologies, Inc. 5555 Bear Lane Corpus Christi, TX 78405
William S. Parker Contact Person: Telephone: (248) 596-1514
September 5, 2001 Date Prepared:
- DEVICE NAME
PulseMaster Erbium Dental Laser System Proprietary Name: Common/Usual Name: Dental Laser System Classification Name: Laser Surgical Instrument
PREDICATE DEVICES 3.
- K983211, Centauri Er: YAG Dental Laser System, Premier Laser Systems, Inc. t
- K992013, DEL2940 Dental Erbium Laser, Continuum Biomedical, Inc. .
- K001527, Fotona Fidelis Er: YAG Laser System and Accessories, Fotona d.d. .
INTENDED USE 4.
The PulseMaster Erbium Dental laser System is intended for the removal of caries and cavity preparation for primary and secondary teeth, the modification and etching of enamel and dentin prior to acid etching, and the incision, excision, ablation, vaporization, and coagulation of soft tissue in oral and maxillofacial surgery including, but not limited to, gingival tissues. 10W
American Dental Technologies, Inc. September 5, 2001 PulseMaster Erbium Dental Laser 510(k)
Page F-1
1
012127 2/2
5. DEVICE DESCRIPTION
The PulseMaster Erbium Dental Laser System is a solid state Er.YAG laser consisting of three internally connected subassemblies: the power supply, the water cooling system, and the Er. YAG pump cavity and resonator assembly. Delivery is via a fiber optic with a sapphire contact tip. The laser delivers up to 400 mJ per pulse, with pulse repetition rates ranging from 10 to 60 Hz and an average power of up to 7.5 Watts.
BASIS FOR SUBSTANTIAL EQUIVALENCE ર્.
The PulseMaster Erbium Dental Laser System has the same intended use and the same or substantially equivalent technical specifications and mechanism of action as compared with the named predicate devices. All of the devices are indicated for both hard and soft tissue applications in dental procedures and oral maxillofacial surgery. All of the devices utilize an Er:YAG solid state laser source operating at a wavelength of 2.94 microns, fiber delivery systems with contact tips, and operating parameters within the same ranges as the PulseMaster Erbium Dental Laser System.
American Dental Technologies, Inc. September 5, 2001 PulseMaster Erbium Dental Laser 510(k)
Page F-2
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/2 description: The image is a black and white logo. The logo is circular in shape and contains text around the perimeter. The text reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA". In the center of the logo is a stylized image of an eagle.
OCT - 4 2001
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
American Dental Technologies, Inc. c/o Ms. Sheila Hemeon-Heyer, JD, RAC Senior Staff Consultant Medical Device Consultants, Inc. 49 Plain Street North Attleboro, Massachusetts 02760
Re: K012127
Trade/Device Name: PulseMaster Erbium Dental Laser System Regulation Number: 878.4810 Regulation Name: Laser surgical instrument for use in general and plastic surgery and dermatology Regulatory Class: II Product Code: GEX, MXF
Dated: July 6, 2001 Received: July 9, 2001
Dear Ms. Hemeon-Heyer:
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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), 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 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 CFR Part 807); labeling (21 CFR Part 801); 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.
3
Page 2 - Ms. Sheila Hemeon-Heyer, JD, RAC
This letter will allow you to begin marketing your device as described in your Section 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 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. 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" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Susie Walk, MD
Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
510(k) Number (if known): K012127
Device Name: PulseMaster Erbium Dental Laser System
Indications for Use:
The PulseMaster Erbium Dental laser System is intended for the removal of caries and cavity preparation for primary and secondary teeth, the modification and etching of cnamel and dentin prior to acid etching, and the incision, excision, ablation, vaporization, and coagulation of soft tissue in oral and maxillofacial surgery including, but not limited to, gingival tissues.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NECESSARY)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use
(Per 21 CFR 801.109)
: 1.
OR
Over-The-Counter Use
(Optional Format 1-2-96)
American Dental Technologies, Inc. PulseMaster Erbium Dental Laser 510(k) September 5, 2001
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