(112 days)
For light curing polymerization of small areas of dental materials capable of curing in the 385 – 425 nm wavelength range.
Fibercure is a handheld dental curing light intended for light curing polymerization of small areas of dental materials capable of curing in the 385 – 425 nm wavelength range. Fibercure functions by delivering light energy to photocurable dental materials, which utilize the light energy to induce a photopolymerization reaction.
Fibercure consists of a pen-shaped handpiece, that is powered with a detachable, rechargeable battery. The handpiece features a user interface containing two push buttons and three status LEDs. The hand-piece is equipped with a solid-state laser diode to generate light energy at a wavelength of 405 ± 5mm and a power of 40 mW. The laser diode is coupled to single-use cure tips containing an optical fiber of 200 µm diameter. The cure tip emits light with an irradiance of 1800 - 2200 mW/cm2 and allows the light to be precisely targeted on the area to be photocured. Fibercure has 2 operation modes to provide either 10 or 20 second irradiation. Fibercure is delivered with a charging stand that is connected to the mains power using a USB power supply. It provides two charging stations and a photometer to confirm the intensity of the emitted light.
Fibercure's handpiece is manufactured from anodized aluminum and houses the electronic assembly. The cure tip consists of a silica-ETFE optical fiber, a stainless-steel fiber guide, a plastic housing and a ceramic ferrule. The detachable battery, charging base and power supply are manufactured from injection-molded plastic.
This is a 510(k) summary for the device Fibercure, an ultraviolet activator for polymerization used in dentistry. The document focuses on establishing substantial equivalence to a predicate device, rather than proving a device meets specific acceptance criteria through a study with statistical measures.
The information provided is primarily a comparison between the subject device (Fibercure) and predicate devices, detailing various technical specifications and indicating that non-clinical tests were performed. However, it does not include the typical acceptance criteria format (e.g., sensitivity, specificity, AUC with thresholds) or a detailed study description to demonstrate that the device "meets" those criteria in the way one would expect for a diagnostic or AI-driven device.
Here's an attempt to answer your questions based on the provided text, while acknowledging the limitations of this type of regulatory submission in addressing your specific points:
Since the document provided is a 510(k) summary for a dental curing light, it focuses on demonstrating substantial equivalence to a predicate device rather than presenting a performance study with acceptance criteria in the manner of a diagnostic or AI-driven device. Therefore, many of your questions, particularly those related to sample size, expert ground truth, MRMC studies, and training sets, are not applicable or cannot be answered from this type of document.
However, I can extract the "performance parameters" and the general conclusion that these parameters meet requirements as a proxy for "acceptance criteria."
1. A table of acceptance criteria and the reported device performance
The document doesn't explicitly state "acceptance criteria" with specific numerical thresholds for aspects like irradiance or depth of cure as pass/fail conditions. Instead, it presents the device's performance parameters and compares them to predicate devices and general standards. The "acceptance criteria" here are implied to be "meeting the requirements of recognized standards and guidance" and being "comparable" to predicate devices.
| Performance Parameter | Acceptance Criteria (Implied / Standard) | Reported Subject Device Performance (Fibercure) |
|---|---|---|
| Intended Use | Photocuring of dental materials | Photocuring of dental materials |
| Indications for Use | For light curing polymerization of dental materials capable of curing in the 385 - 425 nm wavelength range (similar to predicate, within specified wavelength) | For light curing polymerization of small areas of dental materials capable of curing in the 385 - 425 nm wavelength range |
| Irradiance | Comparable to predicate/reference devices | 1800 - 2200 mW/cm^2 |
| Peak Wavelength | Consistent with compatible dental materials | 405 ± 5 nm |
| Depth of Cure | ≥ 1 mm (per ISO 4049:2019, clause 5.2.8) | 1.4 ± 0.1 mm |
| Operational Modes | Functional and comparable to predicate | 10 seconds, 20 seconds |
| Electrical Safety | Meets IEC 60601-1 Class II, Type B requirements | Class II, Type B Applied Part |
| Laser Safety | Meets IEC 60825-1 requirements | Class 3R (Laser diode) |
| Overall Performance | Meets requirements of ISO 10650:2018 and FDA guidance "Dental Curing Lights..." | Meets requirements; comparable to predicate device |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided in the 510(k) summary. The document describes non-clinical performance testing but does not detail the methodology, sample sizes, or provenance of the data in the way you would expect for a clinical study or AI algorithm validation. The testing appears to be laboratory-based physical measurements rather than human-data-driven.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This information is not applicable/provided. The device is a dental curing light, not an AI or diagnostic device that requires expert ground truth for evaluating performance on a test set of cases. The "ground truth" for its performance relates to physical measurements and adherence to technical standards.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable/provided. Adjudication methods are relevant for consensus among experts, typically in diagnostic or AI performance studies on clinical data. For this device, performance is evaluated against technical standards and physical measurements.
5. 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
This information is not applicable/provided. This type of study is specifically for AI-assisted diagnostic devices involving human readers. The Fibercure device is a dental curing light, a tool used by dental professionals, not an AI-driven diagnostic system.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable/provided. This question is relevant for AI algorithms. The Fibercure device is a physical instrument for light curing, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for this device's performance would be derived from physical measurements and adherence to recognized industry and regulatory standards. For example, irradiance is measured with a photometer, wavelength with a spectrometer, and depth of cure according to ISO 4049. It is not based on expert consensus, pathology, or outcomes data in the context of clinical disease.
8. The sample size for the training set
This information is not applicable/provided. The Fibercure device is a physical product (a dental curing light), not a software or AI algorithm that requires a "training set."
9. How the ground truth for the training set was established
This information is not applicable/provided. As above, there is no "training set" for this device.
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November 2, 2023
Lumendo AG Mark Bispinghoff Coo Chemin du Closel 5 Renens, VD 1020 Switzerland
Re: K232076
Trade/Device Name: Fibercure Regulation Number: 21 CFR 872.6070 Regulation Name: Ultraviolet Activator For Polymerization Regulatory Class: Class II Product Code: QNF Dated: October 4, 2023 Received: October 4, 2023
Dear Mark Bispinghoff:
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 (the 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
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Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review. the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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); medical device reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Bobak Shirmohamma વા -ડ
For Michael E. Adjodha, M. ChE., CQIA Assistant Director DHT1B: Division of Dental and ENT Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices
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Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
Submission Number (if known)
Device Name
Fibercure
Indications for Use (Describe)
For light curing polymerization of small areas of dental materials capable of curing in the 385 – 425 nm wavelength range.
Type of Use (Select one or both, as applicable)
| Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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Prepared on: 2023-10-31
510(k) Summary K232076
This 510(k) summary information has been prepared in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.
Applicant 1
| NAME: | Lumendo AG |
|---|---|
| ADDRESS: | Chemin du Closel 5, 1020 Renens (VD), Switzerland |
| CONTACT PERSON: | Dr. Mark Bispinghoff |
| CONTACT DETAILS | +41 44 589 68 02, mark.bispinghoff@lumendo.ch |
Device 2
| DEVICE NAME: | Fibercure |
|---|---|
| COMMON NAME: | Ultraviolet activator for polymerization |
| CLASSIFICATION NAME: | Laser activator for polymerization |
| REGULATION NUMBER: | 872.6070 |
| PRODUCT CODE: | QNF |
Legally marketed predicate devices 3
| DEVICE TYPE | 510(K) # | PREDICATE TRADE NAME | PRODUCT CODE |
|---|---|---|---|
| PRIMARY PREDICATE | K220826 | LED Curing light DB686 nano | EBZ |
| REFERENCE | K201904 | Ultraviolet activator for polymerization | QNF |
Device description summary 4
Fibercure is a handheld dental curing light intended for light curing polymerization of small areas of dental materials capable of curing in the 385 – 425 nm wavelength range. Fibercure functions by delivering light energy to photocurable dental materials, which utilize the light energy to induce a photopolymerization reaction.
Fibercure consists of a pen-shaped handpiece, that is powered with a detachable, rechargeable battery. The handpiece features a user interface containing two push buttons and three status LEDs. The hand-piece is equipped with a solid-state laser diode to generate light energy at a wavelength of 405 ± 5mm and a power of 40 mW. The laser diode is coupled to single-use cure tips containing an optical fiber of 200 µm diameter. The cure tip emits light with an irradiance of 1800 - 2200 mW/cm2 and allows the light to be precisely targeted on the area to be photocured. Fibercure has 2 operation modes to provide either 10 or 20 second irradiation. Fibercure is delivered with a charging stand that is connected to the mains power using a USB power supply. It provides two charging stations and a photometer to confirm the intensity of the emitted light.
Fibercure's handpiece is manufactured from anodized aluminum and houses the electronic assembly. The cure tip consists of a silica-ETFE optical fiber, a stainless-steel fiber guide, a plastic housing and a ceramic ferrule. The detachable battery, charging base and power supply are manufactured from injection-molded plastic.
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Indications for Use 5
For light curing polymerization of small areas of dental materials capable of curing in the 385 - 425 nm wavelength range.
Indications for Use Comparison 6
The subject device, Fibercure, is indicated for light curing polymerization of small areas of dental materials capable of curing in the 385 - 425 nm wavelength range. The predicate device is indicated for light curing polymerization of dental composites, luting materials, cements and other light cured materials. While the subject device refers to the photocuring of dental materials in general, the predicate lists examples of such materials but also includes "other light cured materials" which encompasses the general, dental materials referenced by the subject device. This difference, along with specification of the compatible wavelength range, does not result in a new intended use because both result in an intended use for photo-curing of dental materials.
Substantial Equivalence Comparison 7
Fibercure and the predicate device have the same type of use, treatment site, mechanism of action, components, power source, electrical safety classification, operational modes, infection control for the handpiece, and user interface. Where there are differences between Fibercure and the predicate device, they do not raise different questions of safety of effectiveness. The performance testing results demonstrate that Fibercure functions as intended.
The characteristics of the subject and predicate devices are tabulated and compared below:
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| Device | Subject deviceFibercure | Predicate deviceLED Curing light DB686 nano(K220826) | Reference deviceMonet Curing Laser(K201904) | Comparison |
|---|---|---|---|---|
| Intended use | Photocuring of dental materials | Photocuring of dental materials | Photocuring of dental materials | Identical |
| Indications foruse | For light curing polymerization ofsmall areas of dental materials capa-ble of curing in the 385 - 425 nmwavelength range | For light curing polymerization ofdental composites, luting materials,cements and other light cured mate-rials. | The Monet Curing Laser is a sourceof illumination for curing photo-ac-tivated dental restorative materialsand adhesives. | Similar: The subject device is intendedfor photocuring of dental materials inthe 385 - 425 nm wavelength rangeonly. |
| Type of use | Prescription use | Prescription use | Prescription use | Identical |
| Target users | Dental Professionals | Dental Professionals | Dental Professionals | Identical |
| Treatment site | Oral cavity | Oral cavity | Oral cavity | Identical |
| Mechanism ofaction | Light irradiation of dental material | Light irradiation of dental material | Light irradiation of dental material | Identical |
| Handling instruc-tions | 1. Clean and disinfect all the sur-faces of the handpiece beforeeach use.2. Attach a cure tip to the device.3. Cover the handpiece with the dis-posable Protective Sleeve.4. Power on the device by pressingthe power button.5. Press the Laser button to acti-vate the light. Press once ortwice to select curing time.6. Once the selected curing time haselapsed, the curing program isautomatically terminated. | 1. Clean and disinfect all the sur-faces of the handpiece and thecure tip before each use.2. Attach the cure tip to the device.3. Cover the device with the dis-posable Protective Sleeve.4. Operate the rotary switch toCure to power on the device.5. Press the Start key to activatethe light. Press once or twice toselect curing time.6. Once the selected curing timehas elapsed, the curing programis automatically terminated. | 1 . Disinfect the unit before each use.2. Ensure a charged battery is at-tached to the unit and a barriersleeve is applied.3. Press the switch to "wake up" theunit and go to Standby status.4. Press the switch to go to enter the"Ready" status5. Press the switch to activate the la-ser for 1 second. | Similar: The subject and the predicateand reference all include steps for dis-infection, tip attachment, coveringwith a protective barrier sleeve, anddevice activation by operating aswitch. |
| Device | Subject deviceFibercure | Predicate deviceLED Curing light DB686 nano(K220826) | Reference deviceMonet Curing Laser(K201904) | Comparison |
| Components | Handpiece, charging base withpower meter, cure tip, battery,adapter with power cord, protectivesleeve, user manual | Handpiece, charging base withpower meter, cure tip, battery,adapter with power cord, protectivesleeve, user manual | Handpiece, charging base withpower meter, battery, adapter withpower cord, protective sleeve, usermanual | Identical |
| FDA-RecognizedStandards | IEC 80601-2-60:2019 (Rec.# 4-262)IEC 60601-1:2020 (Rec.# 19-49)IEC 60601-1-2:2020 (Rec.# 19-39)IEC 60825-1:2014ISO 7405:2018 (Rec.# 4-261)ISO 10993-1:2018 (Rec.# 2-258) | IEC 80601-2-60IEC 60601-1IEC 60601-1-2IEC 62471 | IEC 60601-1:2012IEC 60601-1-2:2020 (Rec.# 19-39)IEC 60825-1:2007 (Rec.# 12-273) | Similar: Electrical safety, EMC, lasersafety, and biocompatibility of the sub-ject device was tested according to thecurrently FDA-recognized consensusstandards. |
| Power source | User-replaceable battery | User-replaceable battery | User-replaceable battery | Identical |
| Charging powersupply | Input: 100 – 240 V, 50 – 60 HzOutput: 5 V, 1.2 A | Input: 100 – 240 V, 50 – 60 HzOutput: 5 V, 1.5 A | Input: 100 - 240 V, 50 - 60 HzOutput: 5 V, 2 A | Similar: the subject, predicate, and ref-erence devices have identical inputvoltage and frequency and identicaloutput voltage. The subject device hasa slightly lower output current. |
| Electrical safetyclassification(IEC 60601-1) | Class II, Type B Applied Part | Class II, Type B Applied Part | Class II, Type B Applied Part | Identical |
| Light source &Laser safety class(IEC 60825-1) | Laser diode, class 3R | Light-emitting diode (LED) | Laser diode, class 4 | Similar: the internal light sourceswithin the handpiece are different, butthe light exits the device via a lightguide in all cases. |
| Irradiance(at 2 mm distancefrom the tip) | 1800 - 2200 mW/cm2 | 1600 - 1800 mW/cm2 | 2000 - 2400 mW/cm2 | Similar: The irradiance of the subjectdevice is between the predicate andreference device. |
| Device | Subject deviceFibercure | Predicate deviceLED Curing light DB686 nano(K220826) | Reference deviceMonet Curing Laser(K201904) | Comparison |
| Peak wavelength | $405 \pm 5$ nm | 405 nm, 460 nm | 450 nm | Similar: The peak wavelength of thesubject device is the same as one of thepeak wavelengths of the predicate device. |
| Depth of cure | $1.4 \pm 0.1$ mm | $1.7 \pm 0.1$ mm | $2.1 \pm 0.1$ mm | Similar: all devices pass theISO 4049:2019, clause 5.2.8 requirement of ≥ 1 mm for class 2, opaque restorative materials. |
| Operationalmodes | 10 seconds, 20 seconds | 10 seconds, 20 seconds | 1, 2, or 3 s | Identical (subject & predicate device) |
| Infection control(Handpiece) | Intermediate/ low-level surface dis-infectionUse of protective barrier sleeve | Intermediate/ low-level surface dis-infectionUse of protective barrier sleeve | Intermediate/ low-level surface dis-infectionUse of protective barrier sleeve | Identical |
| Infection control(Cure Tip) | Single-use | ReusableIntermediate/low-level disinfection | ReusableIntermediate/ low-level disinfection | Similar: all devices include infectioncontrol mechanisms for the Cure Tip.The subject device features a single-use cure tip, whereas the predicate andreference devices feature reusable tipsthat require intermediate/ low-leveldisinfection. |
| Dimensions (cm) | 205 x 18 mm | 197 x 13.5 mm | 215 x 19 mm | Similar: the dimensions of the subjectdevice lie between those of the predi-cate and the reference device. |
| User interface | 2 Buttons with indicator lights | 2 Buttons with indicator lights | 1 Button | Identical (subject & predicate device) |
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Non-Clinical Tests Summary 8
Non-clinical performance testing was conducted according to FDA guidance "Dental Curing Lights - Premarket Notification [510(k)] Submissions," issued March 27, 2006, and recognized consensus standard ISO 10650:2018 (FDA recognition #4-252).
Inspection of connections and operating controls was carried out according to ISO 10650:2018, chapter 7.2.1 and 7.2.2. Irradiance, peak wavelength and depth of cure were measured according to the FDA guidance and ISO 4049:2009, chapter 7.10. Irradiance and depth of cure were compared between the subject and the predicate and reference device.
Fibercure meets the requirements of ISO10650:2018 and the FDA guidance "Dental Curing Lights – Premarket Notification [510(k)] Submissions". The determined performance parameters are compatible with the requirements for the intended use and are comparable to those of the predicate device.
Conclusion 9
In conclusion, Fibercure meets the requirements of the applicable standard and guidance, performs as specified and is as safe and effective for its intended use as the predicate device. The Fibercure device shares an identical intended use, and similar indications for use with the predicate device. Fibercure and the predicate device also have the same type of use, target users, treatment site, mechanism of action, components, power source, electrical safety classification, operational modes, infection control for the handpiece, and user interface.
Therefore, the Fibercure device is substantially equivalent to the listed predicate device without raising any different questions of safety or effectiveness.
§ 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.