(35 days)
The DVI Curing Light is a dental curing light that is intended for the photopolymerization of dental resins.
The DVI Curing Light consists of three major components; a handpiece, curved fiber optic end tip, and cradle. The handpiece contains the LED light source and a fiber optic light guide that directs light to the treatment area on the patient. The handpiece is placed in a cradle, which is connected via a plug-in transformer to an AC outlet for charging. A Protective light-shield and Fiber-optic end-tips are accessories provided with the DVI Curing Light, which support the operation and maintenance of the device.
The DVI curing light initiates curing (polymerization) of materials that are activated by photo initiators with an absorption in the wavelength range of between 405 to 470 nm. It is recommended that materials manufacturer's directions be followed for curing times. It is recommended that curing times be extended when curing through the tooth structure or when the distance from the curing light end tip to the material exceeds 3 mm.
The provided text describes a 510(k) summary for the Designs for Vision Inc. Curing Light (DVI Curing Light). However, it does not contain specific acceptance criteria or detailed results of a study proving the device meets acceptance criteria.
The document indicates that performance testing was conducted, but only generally lists the types of tests without providing the criteria or outcomes. Therefore, most of the requested information cannot be extracted from the provided text.
Here is what can be inferred or explicitly stated from the text, with limitations noted:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Functional Performance & Safety | The test results confirm that the proposed DVI Curing Light is safe and effective for use as a curing light. |
| Software and Hardware Verification and Validation | Testing was conducted, but specific criteria or detailed results are not provided. |
| Electrical Safety and Electromagnetic Compatibility | Testing was conducted, but specific criteria or detailed results are not provided. |
| Resin Polymerization Times | Testing was conducted, but specific criteria (e.g., target polymerization times for certain resins) or detailed results are not provided. The document states: "It is recommended that materials manufacturer's directions be followed for curing times." |
| Wavelength Range | The device initiates curing of materials activated by photo initiators with an absorption in the wavelength range of 405 to 470 nm. (This is a characteristic, not an acceptance criterion, but it implies the device must operate within this range). |
| Distance for Curing | It is recommended that curing times be extended when curing through tooth structure or when distance from tip to material exceeds 3 mm. (This is a recommendation, not an acceptance criterion for the device itself). |
Limitations: The document states what kinds of tests were performed (software/hardware V&V, electrical safety/EMC, resin polymerization times), but does not provide the specific acceptance criteria for these tests or the detailed numerical results that demonstrate these criteria were met. It only provides a general statement that "The test results confirm that the proposed DVI Curing Light is safe and effective for use as a curing light."
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size (Test Set): Not specified.
- Data Provenance: Not specified (e.g., country of origin, retrospective/prospective).
3. Number of Experts Used and Their Qualifications for Ground Truth
- This type of device (dental curing light) typically undergoes engineering and performance testing as described in Section 7, rather than ground truth established by experts.
- Therefore, the number and qualifications of experts for ground truth are not applicable in the context described in this document.
4. Adjudication Method for the Test Set
- Not applicable, as expert-based ground truth and adjudication methods are not relevant for the type of device performance testing described.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- No, a MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic devices where human readers interpret images or data, often comparing human performance with and without AI assistance. The DVI Curing Light is a functional medical device, not a diagnostic one.
6. Standalone (Algorithm Only) Performance Study
- No, a standalone (algorithm only) performance study was not done. This concept is primarily relevant for AI/ML-based software devices. The DVI Curing Light is a hardware device with an LED light source; while it has "software and hardware verification and validation," this refers to its internal operational software, not a diagnostic algorithm.
7. Type of Ground Truth Used
- For the performance tests described (e.g., resin polymerization times, electrical safety, software/hardware V&V), the "ground truth" would be established by engineering specifications, regulatory standards, and established scientific principles of material science (for resin curing) and electrical/EMC safety. It is not based on expert consensus, pathology, or outcomes data in the way these terms are typically used for diagnostic or predictive devices.
8. Sample Size for the Training Set
- This concept is not applicable. The DVI Curing Light is a functional device, not an AI/ML device that requires a "training set" for an algorithm.
9. How Ground Truth for the Training Set Was Established
- Not applicable (see point 8).
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JAN 2 5 2005
510(k) Summary for Designs for Vision Inc. Curing Light
1. SPONSOR
Designs for Vision, Inc. 760 Koehler Avenue Ronkonkoma, NY 11779
Contact Person: Richard Feinbloom Telephone: 631-585-3300
Date Prepared: December 20, 2004
2. Device Name
Proprietary Name: DVI Curing Light Common/Usual Name: dental curing light ultraviolet activator for polymerization Classification Name:
3. PREDICATE DEVICES
Dentsply SmartLite (IQ) LED Curing Light (K041372)
Sybron Dental L.E. Demetron (K021797).
4. DEVICE DESCRIPTION
The DVI Curing Light consists of three major components; a handpiece, curved fiber optic end tip, and cradle. The handpiece contains the LED light source and a fiber optic light guide that directs light to the treatment area on the patient. The handpiece is placed in a cradle, which is connected via a plug-in transformer to an AC outlet for charging. A Protective light-shield and Fiber-optic end-tips are accessories provided with the DVI Curing Light, which support the operation and maintenance of the device.
The DVI curing light initiates curing (polymerization) of materials that are activated by photo initiators with an absorption in the wavelength range of
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between 405 to 470 nm. It is recommended that materials manufacturer's directions be followed for curing times. It is recommended that curing times be extended when curing through the tooth structure or when the distance from the curing light end tip to the material exceeds 3 mm.
ડ. INTENDED USE
The DVI Curing Light is a dental curing light that is intended for the photopolymerization of dental resins.
TECHNOLOGICAL CHARACTERISTICS AND SUBSTANTIAL EQUIVALENCE 6.
The proposed and predicate devices consist of a handpiece with a fiberoptic tip. The handpiece of the proposed DVI Curing Light and the predicate devices sit in a cradle. The handpiece is removed from the cradle during operation. The cradles of both the proposed and predicate devices serve as a charging base for the handpieces.
The operational principles of the proposed and predicate devices are identical in that they are LED devices used for photopolymerization of dental resins. The tip of the handpiece is oriented appropriately relative to the material being photopolymerized and the selected treatment time is initiated. In all devices, the light source is an LED light source located in the handpiece.
7. PERFORMANCE TESTING
The following testing was conducted to evaluate the functional performance and safety of the proposed DVI Curing Light:
- Software and hardware verification and validation .
- . Electrical safety and electromagnetic compatibility
- . Resin polymerization times
The test results confirm that the proposed DVI Curing Light is safe and effective for use as a curing light.
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the department's name around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird in flight. The logo is black and white.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN 2 5 2005
Designs for Vision, Incorporated C/O Mary McNamara-Cullinane, RAC Staff Consultant Medical Device Consultants, Incorporated 49 Plain Street North Attleboro, Massachusetts 02760
Re: K043530
Trade/Device Name: DVI Curing Light Regulation Number: 21 CFR 872.6070 Regulation Name: Ultraviolet Activator for Polymerization Regulatory Class: II Product Code: EBZ Dated: December 20, 2004 Received: December 21, 2004
Dear Ms. McNamara-Cullinane:
We have reviewed your Section 510(k) premarket notification of intent to market the indication We have reviewed your Section 510(x) prematics is substantially equivalent (for the indications for referenced above and nave determined the devices marketed in interstate commerce
use stated in the enclosure) to legally market of predicate or to devices that use stated in the enclosure) to regally man keep preadinents, or to devices that prior to May 28, 1976, the enachient with the provisions of the Federal Food, Drug, and Cosmetic
have been reclassified in accordance with the provisions of the Features (PMA have been reclassified in accordance with the provisions of the Act. The may, a Act (Act) that do not require approval of a promatico provisions of the Act. The general therefore, market the device, subject to me general registration, listing of devices, good
controls provisions of the Act include requirements for annual regular and adultera controls provisions of the Act merace requiritions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it If your device is classified (see above) more in the regulations affecting your device can be
may be subject to such additional controls. Existing may of anddition, EDA may p may be subject to such additions, Title 21, Parts 800 to 898. In addition, FDA may publish found in the Code of Featur reserving your device in the Federal Register.
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Page 2 - Mary McNamara-Cullinane, RAC
Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please be advised that I DX 3 Issualled of a volence complies with other requirements of the Act or that FDA nas made a determination and regulations and reactions. You must comply with CEP Page of C ally redular statutes and regulations abut not limited to: registration and listing (21 CFR Part 807); all the Act s requirements; morading, base manufacturing practice requirements as set forth in the quality labeling (21 CFR Part 807), good bart 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) I mis icher with anow you to begin mailing of substantial equivalence of your device to a legally premaired notification: "The PDF interior 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 If you desire specific admission 900 (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small general information on your of your er 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,
Clive S. Liu, Ph.D.
Chiu S. Lin, PhD Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
1043530 510(k) Number (if known):
Device Name: _________________________________________________________________________________________________________________________________________________________________ DVI Curing Light
Indications for Use:
The DVI Curing Light is a dental curing light that is intended for photopolymerization of dental resins.
Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR
Over-the-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Sina Runner
(Division Sign-Off) Urvision of Anesthesiology, General Hospital, Intection Control, Dental Devices
K(k) Number: K0413530
Designs for Vision, Inc. 510(k) Curing Light
December 20, 2004
§ 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.