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.

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.

AI/ML Overview

The provided document describes the FDA 510(k) premarket notification for the LifeRay™ Intraoral Handheld X-ray device. However, it does not contain specific acceptance criteria, reported device performance data, sample sizes for test or training sets, details about ground truth establishment (number/qualifications of experts, adjudication methods), or information about MRMC studies or effect sizes for AI assistance.

The document focuses on demonstrating substantial equivalence to a predicate device (KaVo NOMAD Pro 2 Handheld X-ray System K173319) based on technological characteristics and non-clinical test data adhering to various IEC standards.

The only mention of "clinical performance data" is qualitative: "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." This is a general statement, not a scientific study with quantitative metrics, defined acceptance criteria, or statistical analysis.

Therefore, I cannot provide the requested information about acceptance criteria and a study proving device performance in the format you asked, as the document does not contain this level of detail. It is a regulatory submission focused on substantial equivalence rather than a detailed performance study report.

Here's a breakdown of what can be extracted and what is missing:

Acceptance Criteria and Study for Performance (Information Not Provided in Document)

The document does not describe specific acceptance criteria tied to quantitative performance metrics for diagnostic image quality, nor does it detail a formal study that proves the device meets such criteria through quantitative measures. The "Clinical Performance Data" section is a qualitative statement of comparability.

Information that could not be extracted from the provided document:

A table of acceptance criteria and the reported device performance: This is absent. The document only offers a qualitative statement about image quality being "adequate" and "negligible" differences compared to the predicate.
Sample sizes used for the test set and the data provenance: Not specified.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not specified, as no formal ground truth establishment for a diagnostic performance study is described.
Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable, as no such study is described.
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 device is an X-ray generator, not an AI-powered diagnostic tool.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an algorithm, but hardware.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable, as no formal diagnostic performance study with ground truth is detailed. The "clinical performance data" section refers to a review and comparison of images, implying subjective assessment rather than a structured ground truth process.
The sample size for the training set: Not applicable, as this is a hardware device, not an AI model.
How the ground truth for the training set was established: Not applicable, as this is a hardware device, not an AI model.

What the document does provide regarding the "study" context:

The document focuses on "Non-Clinical Test Data" and "Clinical Performance Data" used to establish Substantial Equivalence to a predicate device.

Non-Clinical Test Data: This section details compliance with various international standards related to electrical safety, electromagnetic compatibility, radiation protection, X-ray tube assemblies, and dental intra-oral X-ray equipment. These are engineering and safety standards, not diagnostic performance metrics based on clinical images.
- IEC 60601-1 Edition 3.2 2020-08 (General Safety)
- IEC 60601-1-2 Edition 4.1 2020 (Electromagnetic Disturbances)
- IEC 60601-4-2 Edition 1.0 2016-05 (Electromagnetic Immunity)
- IEC 60601-1-3 Edition 2.1 2013-04 (Radiation Protection)
- IEC 60601-2-28 Edition 3.0 2017 (X-ray Tube Assemblies)
- IEC 60601-2-65 Edition 1.2 2021 (Dental Intra-oral X-ray Equipment)
- IEC 62133-2: Edition 1.0 2017: (Lithium System)
- IEC 62304 Edition 1.1 2015-06 (Software Life Cycle Processes - Note: The device is explicitly stated as not being a "cyber device" or subject to cybersecurity risks, and "not capable of network connection" which implies minimal software functionality on device itself)
Clinical Performance Data:
- Description: "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."
- Nature: This is a qualitative, comparative assessment, likely performed by the manufacturer or their chosen evaluators, rather than a blinded, multi-reader study with predefined metrics.
- Data Provenance: Not specified (e.g., country of origin, retrospective/prospective). Implicitly, it was likely internal testing by the manufacturer.

Summary Table of What could be extracted:

Category	Detail Provided in Document
Acceptance Criteria & Performance	Qualitative Assessment of Image Quality (for 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."Quantitative Performance (from specifications for comparison):- Exposure Time: 0.01s -1.0s (vs predicate 0.02s-1.0s)- mA: 2.6 mA fixed (vs predicate 2.5 mA fixed)- kVp: Adjustable 60, 65, 70 (vs predicate 60 kVp fixed)
Sample Size (Test Set)	Not specified. (The document states "Clinical radiographic images...have been reviewed and compared," implying a set of images, but no quantity is given.)
Data Provenance	Not specified (e.g., country of origin, retrospective/prospective).
Experts for Ground Truth	Not specified. No formal ground truth establishment process for diagnostic accuracy is described. The "review and comparison" could have been done by internal personnel.
Adjudication Method	Not applicable, as no formal study with expert reads and ground truth adjudication is presented.
MRMC Comparative Study	Not applicable. This device is a hardware X-ray generator, not an AI diagnostic assistant.
Standalone Performance	Not applicable. This is a hardware device, its "performance" is in generating X-rays of a certain quality, which is indirectly assessed via the qualitative image comparison and directly via compliance with safety/performance standards.
Type of Ground Truth Used	Not applicable in the traditional sense of a diagnostic accuracy study. The "clinical performance" here refers to image comparability for the purpose of demonstrating substantial equivalence, not establishing diagnostic accuracy against a verified ground truth.
Training Set Sample Size	Not applicable. This is a hardware device, not an AI model.
Training Set Ground Truth Method	Not applicable. This is a hardware device, not an AI model.

In conclusion, for a handheld intraoral X-ray device seeking 510(k) clearance, the emphasis is on demonstrating safety, effectiveness, and substantial equivalence to a legally marketed predicate device, primarily through engineering and hardware performance standards (Non-Clinical Test Data) and general qualitative image comparability (Clinical Performance Data) rather than rigorous clinical diagnostic accuracy studies common for software algorithms or novel diagnostic tools.

Summary

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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).

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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 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

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Indications for Use

510(k) Number (if known) K241305

Device Name LifeRay™ Intraoral Handheld X-ray

Indications for Use (Describe)

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
Email	: Joseph@lucaslifecare.com
Official Correspondent	: Dave Kim, MBA, MTech Group LLC
Address	: 7505 Fannin St. Suite 610, Houston, TX 77054
Tel	: 713-467-2607
Email	: 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 oralHandheld X-ray System	KaVo NOMAD Pro2Handheld X-ray System(K173319)	Remarks
INDICATIONSFOR USE:	The Lucas Lifecare's LifeRay™handheld is indicated for use onlyby a trained and qualified dentist ordental technicians for both adultand pediatric subjects for producingdiagnostic dental images usingvarious intraoral imagesensors/receptors.	The KaVo NOMAD Pro 2Handheld X-ray System isindicated for use only by atrained and qualified dentist ordental technician for both adultand pediatric subjects as anextraoral diagnostic dental X-ray source to produce X-rayimages using intraoralimagereceptors.	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 skindistance	20 cm	21 cm	Equivalent
Cone diameter	6 cm	6 cm	Same
User Interface	Similar, plus several user-selectable preset times.		Equivalent
Backscatterradiationprotection	6.75" dia. Pb-filled acrylic plasticscatter shield	6.75" dia. Pb-filled acrylic plasticscatter shield	Same
Exposure switch	Trigger located on handset	Trigger located on handset	Same
Tube headmounting	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-ionbattery core pack	Equivalent/Better
Capacity	3.2 A-hr.	1.7 A-hr.	Equivalent/Better
Rechargecapability	After 300 cycles or full drained	70% remaining capacity after300 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 SafetyStandards	IEC 60601-1:2006+A1:2013+AC:2014 +A12:2014 +A2:2020	AAMI ES60601-:2005/(R)2012And 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.

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.

Regulation Number and Section

§ 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.