(57 days)
No
The description focuses on the hardware components and operational parameters of the X-ray device, with no mention of AI or ML for image processing, analysis, or any other function.
No.
The device is indicated for producing diagnostic dental images, which falls under diagnostic imaging, not therapeutic treatment.
Yes
The device is used for "producing diagnostic dental images," which directly indicates its role in diagnosis.
No
The device description explicitly details hardware components such as a battery-operated handheld device, X-ray generator, tube head, battery pack, charging cradle, beam-limiting cone, and backscatter shield. This indicates it is a physical medical device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) in vitro (outside the body) to provide information for diagnosis, monitoring, or screening.
- This device is a dental X-ray system used to produce diagnostic images in vivo (within the body) of the anatomical structures within the mouth.
The description clearly states its purpose is to generate X-rays for creating dental images using intraoral sensors, which is a form of medical imaging performed directly on the patient. This falls under the category of medical devices used for imaging, not in vitro diagnostics.
N/A
Intended Use / Indications for Use
The Lucas Lifecare's Life Ray handheld is indicated for use only by a trained and qualified dentist or dental technicians for both adult and pediatric subjects for producing diagnostic dental images using various intraoral image sensors/receptors.
Product codes
EHD
Device Description
LifeRay™ is a battery-operated, handheld, dental X-ray device. LifeRay™ employs a 100 kHz highfrequency DC X-ray generator. This oil-cooled and shielded tube head is energized by a rechargeable lithium-ion battery pack. The battery is housed under to enable portability. The battery gets charged when the device is docked into its cradle, which is powered through an AC - DC power supply. To focus exposure on the specified zone of the subject, and limit radiation leaking elsewhere out of the device, a shielded beam-limiting cone is engaged to the tube head. This restricts the X-ray field to 60 mm diameter, compatible to dental image receptors. An additional transparent, circular backscatter shield is provided which shall be permanently mounted around the exit of the beam limiting cone to arrest radiation scattering back from the subject, so clinicians can perform in proximity. A wrist lanyard facilitates secure grip, and an inclination display aids in consistent repeatability of radiographs. LifeRay™ employs a fixed tube current of 2.6 mA, but has three selectable tube voltages: 60, 65, or 70 kVp. Exposure duration can be set between 10 ms to 1 s in steps of 10 ms. All these presets can be selected from the home screen of the display through a practical keypad to achieve the best radiograph results.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
X-ray
Anatomical Site
Dental
Indicated Patient Age Range
Adult and pediatric subjects
Intended User / Care Setting
Trained and qualified dentist or dental technicians
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)
Clinical radiographic images using of LifeRay™ and the predicate device have been reviewed and compared to determine the substantial equivalence. Both intraoral X-ray systems generate adequate anatomical details using an intra oral sensor. Difference in edge definition and grayscale of bony structures for both images were negligible. Both intraoral X-ray systems generate sufficient X-ray levels to obtain acceptable edge definition and grayscale of bony and soft tissue images.
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
Not Found
§ 872.1800 Extraoral source x-ray system.
(a)
Identification. An extraoral source x-ray system is an AC-powered device that produces x-rays and is intended for dental radiographic examination and diagnosis of diseases of the teeth, jaw, and oral structures. The x-ray source (a tube) is located outside the mouth. This generic type of device may include patient and equipment supports and component parts.(b)
Classification. Class II.
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July 5, 2024
Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
Lucas Lifecare % Dave Kim Regulatory Affairs Consultant Mtech Group LLC 7505 Fannin St. Suite 610 HOUSTON, TX 77054
Re: K241305
Trade/Device Name: LifeRay™ Intraoral Handheld X-ray Regulation Number: 21 CFR 872.1800 Regulation Name: Extraoral Source X-Ray System Regulatory Class: Class II Product Code: EHD Dated: April 30, 2024 Received: May 9, 2024
Dear Mr. Kim:
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).
1
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 QS 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 mediation-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,
Lu Jiang
Lu Jiang, Ph.D. Assistant Director Diagnostic X-Ray Systems Team DHT8B: Division of Radiological Imaging Devices and Electronic Products OHT8: Office of Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health
2
Indications for Use
510(k) Number (if known) K241305
Device Name LifeRay™ Intraoral Handheld X-ray
Indications for Use (Describe)
The Lucas Lifecare's Life Ray handheld is indicated for use only by a trained and qualified dentist or dental technicians for both adult and pediatric subjects for producing diagnostic dental images using various intraoral image sensors/receptors.
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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Image /page/3/Picture/0 description: The image is a logo for Lucas Lifecare. The logo features a blue circle with a white "L" inside of it. To the right of the circle is the word "LUCAS" in blue, with the word "Lifecare" in gray underneath it. There is a light blue line under the word "LUCAS".
510(k) Summary (K241305)
This summary of 510(k) is being submitted in accordance with requirements of 21 CFR 872.1800
Date 510(k)submitted: 05/01/2024.
Submitter Information: 1.
| Sumitter's Name | : Lucas Lifecare |
|---|---|
| Address | : 2302 Beloit Avenue, Janesville, Wisconsin 53546. |
| Contact Person | : Joseph Paul, CTO |
| Telephone Number | : 608-373-4301, 044 7549 996549, +91 95919-74913 |
| : Joseph@lucaslifecare.com | |
| Official Correspondent | : Dave Kim, MBA, MTech Group LLC |
| Address | : 7505 Fannin St. Suite 610, Houston, TX 77054 |
| Tel | : 713-467-2607 |
| : davekim@mtechgroupllc.com |
2. Trade/ Proprietary Name:
| Trade/ Device Name | : LifeRay™ Intraoral Handheld X-ray |
|---|---|
| System Manufacturer Name | : Lucas Lifecare |
| Common Name | : Portable X-ray System |
| Regulation Name | : Extraoral Source X-ray System |
| Regulation Number | : 21 CFR 872.1800 |
| Primary Product Code | : EHD |
| Classification Name | : Unit, X-ray, Extraoral with Timer |
| Regulatory Class | : II |
| 510K Review Panel | : Dental |
3. Legally Marketed Predicate Device Information: (K173319)
| Trade/ Device Name | : KaVo NOMAD Pro 2 Handheld X-ray System |
|---|---|
| Manufacturer Name | : Aribex |
| Common Name | : Portable X-ray System |
| Regulation Name | : Extraoral Source X-ray System |
| Regulation Number | : 21 CFR 872.1800 |
| Primary Product Code | : EHD |
| Classification Name | : Unit, X-ray, Extraoral with Timer |
| Regulatory Class | : II |
| 510K Review Panel | : Dental |
LUCAS LIFECARE MANUFACTURING SITE| 2302 BELOIT AVENUE, JANESVILLE, WISCONSIN 53546 EMAIL ID | info@lucaslifecare.com PHONE NO | +1 443 742 5556
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Image /page/4/Picture/0 description: The image shows the logo for Lucas Lifecare. The logo consists of a blue circle with a white "L" inside of it, followed by the word "LUCAS" in blue. Below the word "LUCAS" is the word "Lifecare" in a smaller, gray font.
| | LUCAS LifeRay™ Intra oral
Handheld X-ray System | KaVo NOMAD Pro2
Handheld X-ray System
(K173319) | Remarks |
|----------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------|
| INDICATIONS
FOR USE: | The Lucas Lifecare's LifeRay™
handheld is indicated for use only
by a trained and qualified dentist or
dental technicians for both adult
and pediatric subjects for producing
diagnostic dental images using
various intraoral image
sensors/receptors. | The KaVo NOMAD Pro 2
Handheld X-ray System is
indicated for use only by a
trained and qualified dentist or
dental technician for both adult
and pediatric subjects as an
extraoral diagnostic dental X-
ray source to produce X-ray
images using intraoralimage
receptors. | Equivalent |
| MECHANICAL: | | | |
| Size: Body
(mm/inch) | 12.8" L x 5.0" W x 11.3" H | 11"L x 10.5"H x 5.5"W | Similar |
| Weight | 5.3 lbs. | 6.0 lbs. | Better |
| Source to skin
distance | 20 cm | 21 cm | Equivalent |
| Cone diameter | 6 cm | 6 cm | Same |
| User Interface | Similar, plus several user-selectable preset times. | | Equivalent |
| Backscatter
radiation
protection | 6.75" dia. Pb-filled acrylic plastic
scatter shield | 6.75" dia. Pb-filled acrylic plastic
scatter shield | Same |
| Exposure switch | Trigger located on handset | Trigger located on handset | Same |
| Tube head
mounting | Handheld | | Same |
| ELECTRICAL: | | | |
| Tube head | RADII™ KL11-0.4-70 Series | Cyprus PSOC CY8C29866 | Equivalent |
| Energy Source | Rechargeable 21.6 V 3200 mAh Li-
ion battery | Rechargeable 21.6 V DC Li-ion
battery core pack | Equivalent/Better |
| Capacity | 3.2 A-hr. | 1.7 A-hr. | Equivalent/Better |
| Recharge
capability | After 300 cycles or full drained | 70% remaining capacity after
300 cycles | Equivalent |
| Exposure Time | 0.01s -1.0s in 0.01s increments | 0.02s - 1.0s in 0.01s increments | Equivalent/Better |
| mA | 2.6 mA fixed | 2.5 mA fixed | Equivalent/Better |
| kVp | Adjustable kVp 60,65,70 | 60 kVp fixed | Better |
| Electrical Safety
Standards | IEC 60601-1:2006+A1:2013+
AC:2014 +A12:2014 +A2:2020 | AAMI ES60601-:2005/(R)2012
And A1:2012 | Same |
| EMI Standards | IEC60601-1-2 Ed. 4 | IEC60601-1-2 Ed. 4 | Same |
LUCAS LIFECARE MANUFACTURING SITE| 2302 BELOIT AVENUE, JANESVILLE, WISCONSIN 53546 EMAIL ID | info@lucaslifecare.com PHONE NO | +1 443 742 5556
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Image /page/5/Picture/0 description: The image contains the logo for Lucas Lifecare. The logo features a blue circle with a white "L" inside of it. To the right of the circle is the word "LUCAS" in blue, with the word "Lifecare" in gray underneath.
Description of Device: 4.
LifeRay™ is a battery-operated, handheld, dental X-ray device. LifeRay™ employs a 100 kHz highfrequency DC X-ray generator. This oil-cooled and shielded tube head is energized by a rechargeable lithium-ion battery pack. The battery is housed under to enable portability. The battery gets charged when the device is docked into its cradle, which is powered through an AC - DC power supply. To focus exposure on the specified zone of the subject, and limit radiation leaking elsewhere out of the device, a shielded beam-limiting cone is engaged to the tube head. This restricts the X-ray field to 60 mm diameter, compatible to dental image receptors. An additional transparent, circular backscatter shield is provided which shall be permanently mounted around the exit of the beam limiting cone to arrest radiation scattering back from the subject, so clinicians can perform in proximity. A wrist lanyard facilitates secure grip, and an inclination display aids in consistent repeatability of radiographs. LifeRay™ employs a fixed tube current of 2.6 mA, but has three selectable tube voltages: 60, 65, or 70 kVp. Exposure duration can be set between 10 ms to 1 s in steps of 10 ms. All these presets can be selected from the home screen of the display through a practical keypad to achieve the best radiograph results.
ട്. Indications for Use:
The Lucas Lifecare's LifeRay™ handheld is indicated for use only by a trained and qualified dentist or dental technicians for both adult and pediatric subjects for producing diagnostic dental images using various intraoral image sensors/receptors.
6. Description of Substantial Equivalence: Technological Characteristics:
Technological Characteristics:
LifeRay™ has similar design components and operating features as the predicate device, KaVo NOMAD Pro 2 Handheld X-ray System (K173319).
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Image /page/6/Picture/0 description: The image contains the logo for Lucas Lifecare. The logo features a blue circle with a white "L" inside of it. To the right of the circle is the word "LUCAS" in blue, with the word "Lifecare" in gray underneath.
The handheld device features a main unit (tube head), rechargeable battery and charger. main components of the tube head including X-ray tube, internal shielding and The external backscatter shielding are like the predicate device. The functionality of the user interface is also like the predicate device.
The power is supplied by a rechargeable Lithium-Ion battery core pack built into a handset. The design for Liferay is equipped with a 21.6 VDC, 3.2 Ahr battery core pack compared to the predicate device (KaVo NOMAD Pro 2 Handheld X-ray System - K173319) design of 21.6 VDC, 1.7 Ahr. The LifeRay™ battery core pack is compliant with IEC 62133-2.
LifeRay™ is not capable of network connection and it does not contain other connected capabilities. LifeRay™ is not a cyber device and not subject to cybersecurity risks and threats per Section 524B.
Non-Clinical Test Data:
Testing was performed in accordance with the following international standards:
IEC 60601-1 Edition 3.2 2020-08 CONSOLIDATED VERSION (Recognition No19-49)
IEC 60601-1-2 Edition 4.1 2020 Medical Electrical Equipment - Part 1-2: GeneralRequirements For Basic Safety And Essential Performance - Collateral Standard: Electromagnetic Disturbances -Requirements And Tests
IEC 60601-4-2 Edition 1.0 2016-05 Medical electrical equipment - Part 4-2: Guidance and interpretation - Electromagnetic immunity: performance of medical equipment and medical electrical systems (Recognition No: 19-19)
IEC 60601-1-3 Edition 2.1 2013-04 Medical Electrical Equipment - Part 1-3: General Requirements for Basic Safety and Essential Performance – Collateral Standard: RadiationProtection in Diagnostic Xray Equipment (Recognition No: 12-269)
IEC 60601-2-28 Edition 3.0 2017 Medical electrical equipment - Part 2-28: Particular requirements for the basic safety and essential performance of X-ray tube assemblies for medical diagnosis (Recognition No: 12-204)
IEC 60601-2-65 Edition 1.2 2021 Medical electrical equipment - Part 2-65: Particular requirements for the basic safety and essential performance of dental intra-oral-X-ray equipment (Recognition No: 12-340)
IEC 62133-2: Edition 1.0 2017: Lithium System (Recognition No: 19-33)
IEC 62304 Edition 1.1 2015-06 Medical device software life cycle processes (Recognition No: 13-79)
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Image /page/7/Picture/0 description: The image contains the logo for Lucas Lifecare. The logo consists of a blue circle with a white "L" inside, followed by the text "LUCAS" in blue and "Lifecare" in gray. A light blue line is located under the "LUCAS" text.
FDA Guidance Documents Utilized:
Radiation Safety Considerations for X-ray Equipment Designed for Hand-Held Use, issued.
December 24, 2008
Guidance for the Content of Premarket Submissions for Software Contained in MedicalDevices, issued June 14, 2023
Pediatric Information for X-ray Imaging Device Premarket Notifications, issued November 28,2017
Clinical Performance Data:
Clinical radiographic images using of LifeRay™ and the predicate device have been reviewed and compared to determine the substantial equivalence. Both intraoral X-ray systems generate adequate anatomical details using an intra oral sensor. Difference in edge definition and grayscale of bony structures for both images were negligible. Both intraoral X-ray systems generate sufficient X-ray levels to obtain acceptable edge definition and grayscale of bony and soft tissue images.
Conclusion as to Substantial Equivalence:
Based on a comparison of intended use, indications, technological characteristics, principle of operation, features and performance data, the LifeRay™ Handheld Dental X-Ray is deemed to be substantially equivalent to the predicate device.