DUO1 and DUO2

K241649 · Zinnovi, Inc. · MUH · Jul 5, 2024 · Dental

Device Facts

• Record ID: K241649
• Device Name: DUO1 and DUO2
• Applicant: Zinnovi, Inc.
• Product Code: MUH · Dental
• Decision Date: Jul 5, 2024
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.1800
• Device Class: Class 2
• Attributes: 3rd-Party Reviewed

Intended Use

The DUO sensors are intended for any dental practice that uses X-ray equipment for intraoral diagnostic purposes. DUO sensors can be used by trained dental professionals for patients receiving intraoral X-ray examinations and procedures for capturing digital X-ray images. Captured digital X-ray images can be used for examinations and diagnostic purposes with the help of optional image analysis software. The optional image analysis software is not part of this submission. DUO sensors can be used with dental positioning devices and holders to assist with aligning an X-ray source beam with the sensor and anatomy.

Device Story

USB-driven intraoral X-ray sensor; captures dental radiographic images. Scintillating material converts X-rays to visible light; CMOS imager converts light to digital data. Used in dental practices by trained professionals. Device requires connection to PC via USB 2.0 and separate, non-included image analysis software. Sensor assembly supports automatic X-ray detection once armed via software command. Output is digital image displayed on PC screen for diagnostic aid. Benefits include immediate visualization of anatomical structures and pathologies to assist clinical decision-making.

Clinical Evidence

Clinical performance testing involved evaluation of images captured by both the DUO sensor and the predicate device (Brasseler GEM). Images were reviewed by US dentists to confirm the system functions as intended and performs similarly or better than the predicate.

Technological Characteristics

CMOS-based indirect conversion X-ray detector; Cesium Iodide scintillator. USB 2.0 interface. IPx8-equivalent housing (SABIC resin). Biocompatible per ISO 10993. Not sterile. Standards: ANSI/AAMI ES 60601-1, IEC 60601-1-2, IEC 62304.

Indications for Use

Indicated for acquisition of intraoral radiographic images in dental patients. Operated by trained healthcare professionals. May be used with positioning devices or hand-positioned with patient assistance.

Regulatory Classification

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.

Predicate Devices

• Brasseler GEM (K221955)

Submission Summary (Full Text)

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July 5, 2024

Zinnovi Inc. % Abdel Halim President & MRP Global Quality and Regulatory Services 10 Scenic Way MONROE, NJ 08831

#### Re: K241649

Trade/Device Name: DUO1 and DUO2 Regulation Number: 21 CFR 872.1800 Regulation Name: Extraoral source x-ray system Regulatory Class: Class II Product Code: MUH Dated: June 7, 2024 Received: June 7, 2024

### Dear Abdel Halim:

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. 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 located 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 803) for devices or postmarketing safety reporting (21 CFR 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 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 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 ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

Lu Jiang

Lu Jiang, Ph.D. Assistant Director DHT8B: Division of Radiologic 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) K241649

Device Name DU01 and DUO2

#### Indications for Use (Describe)

The DUO Sensors are USB driven intraoral sensors which are intended to acquire intraoral radiographic images. The DUO Sensors shall be operated by trained healthcare professionals, who are educated and competent to perform the acquisition of intraoral radiographs.

The DUO Sensors can be used either in combination with special positioning devices to facilitate positioning and alignment with the X-ray beam or they may also be positioned by hand with the assistance of the patient.

| Type of Use (Select one or both, as applicable) | |
|-------------------------------------------------------------------------------------------------------------------|--|
| <div> <span> <span style="font-size:16px">☑</span> Prescription Use (Part 21 CFR 801 Subpart D) </span> </div> | |
| <div> <span> <span style="font-size:16px">☐</span> Over-The-Counter Use (21 CFR 801 Subpart C) </span> </div> | |

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# K241649

# 510(k) Summary

Date Prepared: June 14th, 2024

# Manufacturer and 510(k) Owner:

Name : Zinnovi, Inc. Address : 135 W. Central Rd, Suite 204, Schaumburg, IL 60195 Telephone: [phone] Official Contact: Swaroop Patel (CEO and Co-founder) Email : [e-mail]

#### Representative/Consultant:

Name : Erica Livingston, RAC Company : Qualomics LLC Address : 5938 Priestly Dr, Suite 103, Carlsbad, CA 92008 Telephone: [phone] Email: [e-mail]

# Identification of New Device

| Owner/Operator: | Zinnovi Inc. |
|--------------------------------|-------------------------------|
| Premarket Notification Number: | K241649 |
| Trade Name: | DUO1 and DUO2 |
| Common Name: | Dental digital X-ray sensor |
| Classification Name: | Extraoral Source X-ray System |
| Product Code: | MUH |
| Submission Type: | 510(k) |
| Classification: | Class II |
| Panel/Medical Specialty: | Radiology/Dental |
| Regulation Number: | 21 CFR 872.1800 |
| Manufacturer: | Zinnovi Inc. |

# Identification of Predicate Device

| Owner/Operator: | RealCloud Imaging Inc. doing business as RealCloud Imaging |
|-----------------------------------------------|------------------------------------------------------------|
| 510(k) Premarket Notification Number: K221955 | |
| Trade Name: | Brasseler GEM |

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Common Name: Dental digital X-ray sensor Classification Name: Extraoral Source X-ray system Product Code: MUH Classification: Class II Panel/Medical Specialty: Radiology/Dental Regulation Number: 21 CFR 872.1800 Manufacturer: RealCloud Imaging Inc. doing business as RealCloud Imaging

# Device Description

The DUO sensors are USB-driven digital X-ray sensors designed for health care professionals who are already acquainted with the standard procedures for acquiring dental intraoral radiographs. Digital X-ray imaging is an aide for diagnosis and should always be confirmed by the doctor using appropriate additional diagnostic aides, professional judgment, and experience.

The DUO Sensors are indirect converting X-ray detectors. A scintillating material converts the incident Xrays into visible light, this light is coupled optically to a CMOS technology light detection imager, and then converted to digital data.

The design of the sensor assembly supports the automatic detection of incident X-rays to generate digital images for intraoral applications, once armed via a software command. The digital image created is immediately visible on the screen of a personal computer connected to the DUO sensor through the standard USB port. For DUO sensors to be used in a dental practice, an optional image analysis software will be necessary. Image analysis software is not part of the submission. DUO captured X-ray images are suitable for recognition of normal anatomical structures, dental pathologies, and abnormal conditions.

The DUO sensors support USB2.0 connectivity to computers using a dedicated electronic assembly and a sensor software driver. Functions of the DUO sensors are controlled by software drivers and utilities support sensor activation and settings.

The DUO sensors are manufactured with the same device firmware as the predicate device, Brasseler GEM.

# Indications for Use

The DUO Sensors are USB driven intraoral sensors which are intended to acquire intraoral radiographic images. The DUO Sensors shall be operated by trained healthcare professionals, who are educated and competent to perform the acquisition of intraoral radiographs.

The DUO Sensors can be used either in combination with special positioning devices to facilitate positioning and alignment with the X-ray beam or they may also be positioned by hand with the assistance of the patient.

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#### Intended Use

The DUO sensors are intended for any dental practice that uses X-ray equipment for intraoral diagnostic purposes. DUO sensors can be used by trained dental professionals for patients receiving intraoral X-ray examinations and procedures for capturing digital X-ray images. Captured digital X-ray images can be used for examinations and diagnostic purposes with the help of optional image analysis software. The optional image analysis software is not part of this submission. DUO sensors can be used with dental positioning devices and holders to assist with aligning an X-ray source beam with the sensor and anatomy.

# Comparison Table

The following comparison table compares Zinnovi DUO to the predicate device, Brasseler GEM, with respect to intended use, indications of use, environment of use, limitations of use, technical performance, and technological characteristics, and provides more detailed information regarding the basis for the determination of substantial equivalence.

| Descriptive<br>Information | Zinnovi DUO | Brasseler GEM | VERDICT |
|--------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------|
| 510(k) Number | K241649 | K221955 | NA |
| Manufacturer | Zinnovi Inc. | RealCloud Imaging Inc. doing<br>business as RealCloud<br>Imaging | NA |
| Trade Name | DUO1<br>DUO2 | Brasseler GEM10<br>Brasseler GEM15<br>Brasseler GEM20 | NA |
| Classification Name | Digital X-ray Sensor | Digital X-ray Sensor | Same |
| Classification | Class II | Class II | Same |
| Classification Panel/<br>Medical Specialty | Radiology/Dental | Radiology/Dental | Same |
| Regulation Number | 21 C.F.R. §872.1800 | 21 C.F.R. §872.1800 | Same |
| Product Code | MUH | MUH | Same |
| Number of Sensors | 2 | 3 | Different |
| Sensor Exterior Sizes | 36.36 mm x 24.53.mm | 36.36 mm x 24.53.mm | Same |
| | | 38.83 mm x 29.63 mm | NA |
| | 41.80 mm x 30.48 mm | 41.80 mm x 30.48 mm | Same |
| Sensor Imaging Sizes | 30.26 mm x 20.32 mm | 30.26 mm x 20.32 mm | Same |
| | | 33.15 mm x 26.25 mm | NA |
| | 36.08 mm x 26.25 mm | 36.08 mm x 26.25 mm | Same |
| | All with four clipped corners | All with four clipped corners | Same |
| Overall Imaging Areas | 615 mm2 | 615 mm2 | Same |
| | | 870 mm2 | NA |
| | 947.1mm2 | 947.1mm2 | Same |
| | | | |
| Pixel Size | 19.5 μm | 19.5 μm | Same |
| Image Resolution | 1539 x 1026 pixels<br>(1.70 M pixels) | 1539 x 1026 pixels<br>(1.70 M pixels) | Same |
| | | 1692 x 1324 pixels<br>(2.2 M Pixels) | NA |
| | 1842 x 1324 pixels<br>(2.40 M pixels) | 1842 x 1324 pixels<br>(2.40 M pixels) | Same |
| | | | |
| X-Ray Resolution | 20 visible lp/mm | 20+ visible lp/mm | Different |
| Dynamic Range | 16,384:1 | 16,384:1 | Same |
| Technology | CMOS | CMOS | Same |
| Scintillator Technology | Cesium lodide | Cesium lodide | Same |
| Operating System | Microsoft Windows 10 and<br>Windows 11 | Microsoft Windows 7 and 10 | Different |
| Extraoral source | X-ray system | X-ray system | Same |
| Interface to PC | USB 2.0, Type A | USB 2.0, Type A | Same |
| Cable Length | 0.6m and 1.9m | 1.9 m and 2.9 m | Different |
| Power Consumption | 0.8 Watts Max | 0.8 Watts Max | Same |
| Electrical Rating | DC 5V, 350 mA max | DC 5V, 350 mA max | Same |
| Sterilization | Not suitable for sterilization | Not suitable for sterilization | Same |
| Housing | IPx8 Equivalent ISO 10993-1<br>Biocompatible | IPx8 Equivalent ISO 10993-1<br>Biocompatible | Same |
| Indications for use | The DUO Sensors are USB<br>driven digital intraoral sensors<br>which are intended to acquire<br>intraoral radiographic images.<br>The DUO Sensors shall be<br>operated by trained<br>healthcare professionals, who<br>are educated and competent<br>to perform the acquisition of<br>intraoral radiographs.<br>The DUO Sensors can be used<br>either in combination with<br>special positioning devices to<br>facilitate positioning and<br>alignment with the X-ray beam<br>or they may also be positioned<br>by hand with the assistance of<br>the patient. | Brasseler GEM is a USB<br>driven digital intraoral X-ray<br>sensor which is intended to<br>acquire dental radiographic<br>images.<br>Brasseler GEM must be<br>operated by healthcare<br>professionals who have<br>been trained and are<br>competent using various<br>methods of acquiring<br>radiographic images of<br>dental anatomy. Brasseler<br>GEM can be used with<br>dental positioning devices<br>and holders to assist with<br>aligning an X-ray source<br>beam with the sensor and<br>anatomy. Brasseler GEM can<br>also be aligned by hand with<br>assistance of the patient. | Same |
| Intended Use | The DUO sensors are intended<br>for any dental practice that<br>uses X-ray equipment for<br>intraoral diagnostic purposes.<br>DUO sensors can be used by<br>trained dental professionals<br>for patients receiving intraoral<br>X-ray examinations and<br>procedures for capturing<br>digital X-Ray images. Captured<br>digital X-ray images can be<br>used for examinations and<br>diagnostic purposes with the | Brasseler GEM is intended<br>for any dental practice that<br>uses X-ray equipment for<br>intraoral diagnostic<br>purposes. Brasseler GEM<br>can be used by trained<br>dental professionals for<br>patients receiving intraoral<br>X-ray examinations and<br>produces digital images for<br>patients receiving intraoral<br>X-ray examinations for<br>diagnostic purposes. An<br>image analysis software is | Same |
| | help of optional image analysis<br>software. | not part of this submission. | |
| | The optional image analysis<br>software is not part of this | When Brasseler GEM is to<br>be used in a dental practice, | |
| | submission. DUO sensors can<br>be used with dental | an optional software will be<br>necessary. Brasseler GEM is | |
| | positioning devices and<br>holders to assist with aligning | a USB-driven digital intraoral<br>X-ray sensor which is | |
| | an X-ray source beam with the<br>sensor and anatomy. | intended to acquire dental<br>radiographic images. | |
| | | Brasseler GEM must be | |
| | | operated by healthcare | |
| | | professionals who have | |
| | | been trained and are | |
| | | competent using various | |
| | | methods of acquiring | |
| | | radiographic images of | |
| | | dental anatomy. Brasseler | |
| | | GEM can be used with | |
| | | dental positioning devices | |
| | | and holders to assist with | |
| |…