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.

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.

AI/ML Overview

The provided text is a 510(k) Summary for a medical device called the "PulseMaster Erbium Dental Laser System." This type of document is for demonstrating substantial equivalence to a predicate device, not for proving a device meets specific acceptance criteria through a study with detailed performance metrics. As such, most of the requested information regarding acceptance criteria, study design, and performance metrics is not available in the given text.

Here's a breakdown of what can and cannot be answered based on the provided document:

Acceptance Criteria and Device Performance

No specific acceptance criteria in terms of quantitative performance metrics (e.g., sensitivity, specificity, accuracy) are reported. This document focuses on demonstrating substantial equivalence to legally marketed predicate devices primarily based on intended use, technical specifications, and mechanism of action, rather than a clinical trial with performance targets.

Acceptance Criteria	Reported Device Performance
Not specified	Not specified

Study Information

Sample size used for the test set and the data provenance: Not applicable. No test set or clinical study to evaluate specific performance metrics is described in this 510(k) summary. The basis for substantial equivalence is a comparison to predicate devices, not a new clinical study with a test set.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No test set requiring ground truth establishment by experts is described.
Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable.
If a multi-reader, multi-case (MRMC) comparative effectiveness study was done, if so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This document describes a dental laser system, not an AI-assisted diagnostic or therapeutic device.
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an algorithmic device.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable.
The sample size for the training set: Not applicable. This is a hardware device, not a machine learning algorithm requiring a training set.
How the ground truth for the training set was established: Not applicable.

Summary of What the Document Does State:

Intended Use: The PulseMaster Erbium Dental Laser System is intended for:
- Removal of caries and cavity preparation for primary and secondary teeth.
- Modification and etching of enamel and dentin prior to acid etching.
- Incision, excision, ablation, vaporization, and coagulation of soft tissue in oral and maxillofacial surgery (including gingival tissues).
Basis for Substantial Equivalence: The device is deemed substantially equivalent to predicate devices (K983211, K992013, K001527) because it shares:
- The same intended use.
- Substantially equivalent technical specifications.
- The same mechanism of action.
- Indication for both hard and soft tissue applications.
- Utilizes an Er:YAG solid state laser source operating at 2.94 microns.
- Employs fiber delivery systems with contact tips.
- Operates within the same parameter ranges as the predicate devices.

Summary

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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.

American Dental Technologies, Inc. September 5, 2001 PulseMaster Erbium Dental Laser 510(k)

Page F-1

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012127 2/2

5. DEVICE DESCRIPTION

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

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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.

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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

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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.

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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V2 (Division Sign-Off) Division of General, Restorative and Neurological Devices ...

510(k) Number_10 =============================================================================================================================================================

Regulation Number and Section

§ 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.