The PlasmaCure BXe Curing Light is a source of illumination for curing dental restorative materials and is a source of illumination for tooth whitening activities performed in dentistry.

Device Description

The PlasmaCure BXe is a device used for the polymerization of dental materials using blue light. It consists of a base unit and a cord connected hand piece. The molded plastic control unit (base unit) contains a power inlet receptacle for a detachable mains power cord, fuse holder and fuses, power supply & controller printed circuit board (control circuitry for lamp and cooling fan functions). The cord connected hand piece contains a printed circuit board, lamp reflector module assembly, optical filter assembly, fibertip insert and fiber optic tip that generates blue light energy having the wavelength range of approximately 385-495 nm. An external trigger switch (hand piece) activates the curing lamp. The emitted intensity and exposure time level depends on which type of eeleCoolTip™ is inserted in the hand piece and which key was last activated on the keypad of the base unit. The hand piece also has a removable and rotatable light shield that will protect the user when in operation.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and supporting study for the PlasmaCure BXe device:

1. Table of Acceptance Criteria and Reported Device Performance

The provided document (K033795) is a 510(k) summary for a dental curing light. It primarily focuses on demonstrating substantial equivalence to predicate devices rather than establishing novel acceptance criteria for a new type of medical device. The "acceptance criteria" here are implicitly tied to the performance of existing, legally marketed predicate devices.

Acceptance Criteria Category	Specific Criteria/Standard (Implicit)	Reported Device Performance (PlasmaCure BXe)
Effectiveness	Polymerization of dental restorative materials and tooth whitening (similar to predicate devices and other plasma arc lights).	"The PlasmaCure BXe performed similar to other plasma arc lights, & polymerized faster than the halogen, laser, & LED lights evaluated at that time."
Safety - Electrical	Compliance with electrical safety standards (UL 2601-1, IEC 60601-1, CAN/CSA-C22.2, IEC 60601-1-4).	"Safety: Pending Approval of UL 2601-1 including IEC 60601-1. CAN/CSA-C22.2 and evaluation to IEC 60601-1-4."
Safety - EMC/EMI	Compliance with electromagnetic compatibility/interference standards (EN50081-1, FCC 15, EN55011 Class B).	"Immunity testing to EN50081-1 as well as Radiated and Conducted emissions testing to FCC 15 and EN55011 Class B limits to 1 GHz."
Biocompatibility	Meeting biocompatibility requirements.	"Bench testing was performed, which included biocompatibility... to confirm that the PlasmaCure BXe is equivalent to the predicate devices. All bench testing results met specified requirements."
Sterilization	Meeting sterilization requirements.	"Bench testing was performed, which included... sterilization... to confirm that the PlasmaCure BXe is equivalent to the predicate devices. All bench testing results met specified requirements."
Packaging	Meeting packaging requirements.	"Bench testing was performed, which included... packaging... to confirm that the PlasmaCure BXe is equivalent to the predicate devices. All bench testing results met specified requirements."
Functionality	Performing its intended function similar to predicate devices.	"Bench testing was performed, which included... functionality to confirm that the PlasmaCure BXe is equivalent to the predicate devices. All bench testing results met specified requirements."
Environmental & Dynamic Testing	Withstanding environmental and dynamic stresses (temperature, humidity, shock).	"Environmental & Dynamic Testing including temperature, humidity, Mil-Std-810-E Method 514.4 category 1 and shock testing."

2. Sample Size Used for the Test Set and Data Provenance

Test Set Sample Size: Not explicitly stated as a number of "cases" or "patients" in the context of clinical studies. The testing described is primarily bench testing of the device itself (biocompatibility, sterilization, packaging, functionality, environmental, electrical safety, EMC). For the effectiveness claim ("polymerized faster than..."), it mentions "Independent Testing Facility test results for equivalence (nonclinical performance data)," but the specific number of tests or samples (e.g., how many dental materials were tested, how many times) is not provided.
Data Provenance: The data comes from bench testing conducted by eele Laboratories and an unnamed "Independent Testing Facility." There is no mention of human clinical data, retrospective, or prospective studies involving patients. The focus is on the device's technical specifications and performance characteristics.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

Number of Experts: Not applicable. The "ground truth" for this device's performance is based on established engineering standards, material science principles (e.g., polymerization rates of dental resins), and comparisons to the technical specifications of predicate devices, not on expert clinical interpretation of medical images or patient outcomes.
Qualifications of Experts: Not applicable in the traditional sense of clinical experts. The "expertise" involved would be in engineering, materials science, and regulatory compliance.

4. Adjudication Method for the Test Set

Not applicable. As described above, the "test set" involves laboratory and bench testing against established performance metrics and engineering standards, not subjective assessments requiring adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No, an MRMC comparative effectiveness study was not done. This type of study typically involves multiple human readers interpreting medical images with and without AI assistance to measure diagnostic accuracy. The PlasmaCure BXe is a medical device (dental curing light), not an AI diagnostic tool.
Effect size of human readers with vs. without AI: Not applicable for this device.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done

Partially applicable, but in a different context. The "standalone performance" of the PlasmaCure BXe refers to its ability to cure dental materials and provide illumination for tooth whitening as a device, independent of direct human judgment being assessed. The bench testing performed demonstrates the device's functional performance in a "standalone" capacity, apart from human interaction influencing the curing process itself (though a human operates the device). There is no "algorithm" in the sense of AI being evaluated here.

7. The Type of Ground Truth Used

The ground truth for this device is based on objective measurements of physical properties and compliance with engineering and safety standards.
- Effectiveness: Measured polymerization rates of dental materials (e.g., hardness, depth of cure) and light intensity/wavelength for tooth whitening, compared to industry benchmarks and predicate devices.
- Safety: Compliance with electrical safety, EMC, and biocompatibility standards.
- Functionality: Verification that the device operates as designed (e.g., light output, control features).

8. The Sample Size for the Training Set

Not applicable. The PlasmaCure BXe is a physical device (dental curing light), not an AI algorithm. Therefore, there is no "training set" in the context of machine learning. The device's design, engineering, and manufacturing processes rely on established principles, specifications, and quality control, not on data training.

9. How the Ground Truth for the Training Set was Established

Not applicable. As there is no training set for an AI algorithm, there is no ground truth established for a training set.

Summary

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eele Laboratories

eele Laboratories, LLC email: Info@eele.com 1 (631) 244-0051 1 (631) 244-0053 50 Orville Drive, Bohemia NY 11716-2519

DEC 1 9 2003

8. 510 (k) Summary

K033795

This summary of 510 (k) safety and effectiveness information is being submitted in accordance with the requirements of 21 CFR Part 807.87(h).

eele Laboratories, LLC 50 Orville Drive Bohemia, N.Y. 11716 Phone: (631) 244-0051 Fax: (631) 244-0053

Name of Applicant/Contact: Signature of Applicant: Dated:

Robert Grasman (Phone extension; 106)

October 20, 2003

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ele Laboratorie

Proposed Device

Ultraviolet activator for polymerization 0 Device Classification Name:
Dental Curing Light

PlasmaCure BXe

21 CFR 872.6070

EBZ

Device Common Name: 0
Trade/Proprietary Name: 0
- Regulation Number:
0 Regulatory Class: O
Product Code: O
Review Advisory Committee: Dental 0

Substantial Equivalence

DeviceName	Device/ClassificationName	Owner/OperatorApplicant	510 (k)No.	ProductCode	Reg. #
Rmo PlasmaCuring Light	Activator,Ultraviolet, forPolymerization	Lokki LasersMedicaux	K024374	EBZ	872.6070
Q-Lux Plasma100 Light CureUnit	Activator,Ultraviolet, forPolymerization	Rolence EnterpriseCo., LTD	K001719	EBZ	872.6070
Optilux 501	Activator,Ultraviolet, forPolymerization	Kerr Corporation(Danbury)	K020091	EBZ	872.6070

The PlasmaCure BXe addressed in this premarket notification, is substantially equivalent to the following commercially dental curing lights:

Device Description

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eele Laboratories

eele Laboratories, LLC email: Into@eele.com 1 (631) 244-0051 1 (631) 244-0053 50 Orville Drive, Bohemia NY 11716-2519

Statement of Indications for Use

The PlasmaCure BXe Curing Light is a source of illumination for curing dental restorative materials and is a source of illumination for tooth whitening activities performed in dentistry.

Device Testing Results and Conclusion

Bench testing was performed, which included biocompatibility, sterilization, packaging, and functionality to confirm that the PlasmaCure BXe is equivalent to the predicate devices. All bench testing results met specified requirements.

Summary of Technological Characteristics to Predicate Devices

The Optilux 501 utilizes a halogen light source that is located in the plastic O hand piece (handle) that also includes the optical filter assembly and fiber optic light guide. The light emanates from the light guide that is attached to the hand piece.
The other comparable devices have their light source located in the control O unit (box) and the light travels through a light pipe (conduit) and then the light guide. These devices are listed to demonstrate the "Plasma Arc" technology using a Xenon Arc Lamp.
0 The PlasmaCure BXe has the light source (similar to Optilux 501) in the plastic hand piece (handle) as well as the optical filter assembly and fiber optic guide. Instead of having the light source in the control unit (box) as above, it is located in the hand piece.

Safety and Effectiveness Information Supporting the Substantial Equivalence

The PlasmaCure BXe complies with the following standards, practices, and guidance's:

Effectiveness: Independent Testing Facility test results for equivalence (nonclinical performance data).
The PlasmaCure BXe performed similar to other plasma arc lights, & polymerized faster than the halogen, laser, & LED lights evaluated at that time.
Safety: Pending Approval of UL 2601-1 including IEC 60601-1. CAN/CSA-C22.2 and evaluation to IEC 60601-1-4. In addition Immunity testing to EN50081-1 as well as Radiated and Conducted

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ele Laboratories

emissions testing to FCC 15 and EN55011 Class B limits to 1 GHz.

Independent Testing Facilities:

· Software development, verification, and validation process is also pending to ensure performance to specifications, Federal Regulations and user requirements.
Environmental & Dynamic Testing including temperature, o humidity, Mil-Std-810-E Method 514.4 category 1 and shock testing.

Conclusion

The intended use and technological features of the PlasmaCure BXe do not differ from the legally marketed predicate device(s). Both the PlasmaCure BXe and the predicate device(s) have the same materials and product design. The PlasmaCure BXe performs as well as or better than the predicate devices. This conclusion is based upon the devices' similarities in functional design, materials, indications for use, and methods of construction. The subject device is substantially equivalent to the predicate devices with regard to intended use, indications, device characteristics, method of use, labeling, materials, and safety features.

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Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three curved lines representing its wings, positioned to the right of the text. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular fashion around the left side of the eagle.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC 1 9 2003

Eele Laboratories, LLC Mr. Neil E Devine Responsible Third Party Official Entela, Incorporated 3033 Madison Avenue, SE Grand Rapids, Michigan 49548

Re: K033795

Trade/Device Name: PlasmaCure Regulation Number: 872.6070 Regulation Name: Ultraviolet Activator for Polymerization Regulatory Class: Product Code: EBZ Dated: December 5, 2003 Received: December 5, 2003

Dear Mr. Devine:

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.

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Page 2 -Mr. Devine

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.

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), please contact the Office of Compliance at (301) 594-4613. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act 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 vours.

Chiu-Ling, Ph.D.

Chiu Lin, Ph.D. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

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5. Statement of Indications for Use

1 of 1 Page

510(k) Number (if known): K033795

Device Name: PlasmaCure BXe

Indications For Use:

The PlasmaCure BXe Curing Light is a source of illumination for curing dental restorative materials and is a source of illumination for tooth whitening activities performed in dentistry.

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Susan Ruan

on of Anesthesiolog Infection Control, Dent

(Optional Format 3-10-98)

510(k) Number. K053245

Prescription Use
(Per 21 CFR 801.109)

Page 5-21 of 45

Regulation Number and Section

§ 872.6070 Ultraviolet activator for polymerization.

(a)
Identification. An ultraviolet activator for polymerization is a device that produces ultraviolet radiation intended to polymerize (set) resinous dental pit and fissure sealants or restorative materials by transmission of light through a rod.(b)
Classification. Class II.