(28 days)
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.
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.
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.
This submission describes a dental digital X-ray sensor, DUO1 and DUO2, which is substantially equivalent to the predicate device, Brasseler GEM.
Here's the breakdown of the acceptance criteria and supporting study details:
1. Table of Acceptance Criteria and Reported Device Performance
The FDA submission for K241649 is a 510(k) premarket notification, which relies on demonstrating substantial equivalence to a legally marketed predicate device rather than setting specific quantifiable acceptance criteria for novel claims. Therefore, the "acceptance criteria" here refer to demonstrating comparable performance to the predicate device (Brasseler GEM) for key technical aspects.
| Acceptance Criteria (Demonstrates Substantial Equivalence to Brasseler GEM) | Reported Device Performance (DUO1 and DUO2) |
|---|---|
| Mechanical/Physical Equivalence | |
| Sensor Exterior Sizes | DUO1: 36.36 mm x 24.53 mm (Same as Brasseler GEM) DUO2: 41.80 mm x 30.48 mm (Same as Brasseler GEM) |
| Sensor Imaging Sizes | DUO1: 30.26 mm x 20.32 mm (Same as Brasseler GEM) DUO2: 36.08 mm x 26.25 mm (Same as Brasseler GEM) |
| Overall Imaging Areas | DUO1: 615 mm² (Same as Brasseler GEM) DUO2: 947.1 mm² (Same as Brasseler GEM) |
| Clipped Corners | All with four clipped corners (Same as Brasseler GEM) |
| Housing Biocompatibility | IPx8 Equivalent ISO 10993-1 Biocompatible (Same as Brasseler GEM). Biocompatibility is based on the predicate device as materials/manufacturing are identical. SABIC resin used is the same as the predicate device. |
| Sterilization suitability | Not suitable for sterilization (Same as Brasseler GEM). Manufacturer recommends hygienic barrier. |
| Imaging Performance Equivalence | |
| Pixel Size | 19.5 μm (Same as Brasseler GEM) |
| Image Resolution (pixels) | DUO1: 1539 x 1026 pixels (1.70 M pixels) (Same as Brasseler GEM) DUO2: 1842 x 1324 pixels (2.40 M pixels) (Same as Brasseler GEM) |
| X-Ray Resolution (lp/mm) | 20 visible lp/mm (Predicate: 20+ visible lp/mm). The submission states both have a theoretical maximum resolution of 25 lp/mm. This is considered "Different" in the comparison table but is addressed as substantially equivalent in the "Meaningful Differences" section by clarifying theoretical maximums are the same. |
| Dynamic Range | 16,384:1 (Same as Brasseler GEM) |
| Technology (CMOS) | CMOS (Same as Brasseler GEM) |
| Scintillator Technology | Cesium Iodide (Same as Brasseler GEM) |
| MTF (Modulation Transfer Function) | Identical to Brasseler GEM (due to using the exact same sensor components from the same contract manufacturer). |
| DQE (Detective Quantum Efficiency) | Substantially equivalent to Brasseler GEM (determined by BAE Systems Imaging Solutions). |
| Electrical/Software Equivalence | |
| Operating System Compatibility | Microsoft Windows 10 and Windows 11 (Predicate: Windows 7 and 10). This indicates broader compatibility for later OS versions for DUO. |
| Interface to PC | USB 2.0, Type A (Same as Brasseler GEM) |
| Power Consumption | 0.8 Watts Max (Same as Brasseler GEM) |
| Electrical Rating | DC 5V, 350 mA max (Same as Brasseler GEM) |
| Cable Length | 0.6m and 1.9m (Predicate: 1.9m and 2.9m). Stated that cable length has no effect on performance. |
| Software Functionality | Functions controlled by software drivers and utilities support sensor activation and settings. Simple API for integration with existing FDA-cleared image capture/dental imaging software. |
| Clinical Performance | |
| Visual Assessment of Clinical Images | Performed similar or better than the predicate device (Brasseler GEM) as evaluated by US dentists. |
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Description: The document refers to "clinical images captured with both the devices in a performance testing report which were evaluated by US dentists."
- Sample Size: The exact number of patients or images in the clinical performance test set is not specified in the provided text.
- Data Provenance: The images were evaluated by "US dentists." It is not explicitly stated whether the data was retrospective or prospective. Given the clinical image evaluation, it suggests real-world acquisition but the exact study design (e.g., controlled prospective collection vs. retrospective existing images) is not detailed.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- Number of Experts: The document states that the clinical images "...were evaluated by US dentists." The exact number of dentists is not specified.
- Qualifications of Experts: The experts are described as "US dentists." Specific qualifications such as years of experience, subspecialty (e.g., board-certified oral and maxillofacial radiologists), or academic affiliations are not provided.
4. Adjudication Method for the Test Set
- Adjudication Method: The document only states that images "were evaluated by US dentists." It does not describe any specific adjudication method (e.g., 2+1, 3+1 consensus, independent reads with no consensus).
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- A formal MRMC comparative effectiveness study that quantifies improvements in human reader performance (e.g., AUC, sensitivity, specificity) with AI versus without AI assistance was not performed or described. The clinical performance testing involved dentists evaluating images from both devices, implying a comparative visual assessment, but not a controlled MRMC study in the context of AI assistance. The device itself is an intraoral sensor, not an AI diagnostic tool.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
- This device (DUO sensors) is a hardware component for acquiring images, not an AI algorithm for image analysis. Therefore, a standalone algorithm performance study is not applicable in the traditional sense. The submission states, "Image analysis software is not part of the submission" and "The optional image analysis software is not part of this submission."
7. Type of Ground Truth Used
- For the clinical performance testing, the ground truth was based on the visual evaluation and judgment of US dentists comparing images from DUO sensors to those from the predicate Brasseler GEM. This can be considered a form of expert consensus/reader judgment on image quality and diagnostic utility, but specific "ground truth" for disease presence/absence (like pathology or outcomes data) is not explicitly detailed as this is not an AI diagnostic device. The statement "DUO captured X-ray images are suitable for recognition of normal anatomical structures, dental pathologies, and abnormal conditions" implies the images were assessed for their ability to show such features.
8. Sample Size for the Training Set
- The provided text does not mention a training set for the DUO sensors. As this is a hardware device (sensor) and not an AI diagnostic algorithm, a "training set" in the context of machine learning is not applicable here. The device uses established CMOS and scintillator technologies and is compared against a predicate device.
9. How the Ground Truth for the Training Set Was Established
- Since there is no mention of a training set for an AI algorithm, the concept of establishing ground truth for a training set is not applicable to this submission.
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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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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) | |
|---|---|
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) | |
| ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
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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: +1 (224) 801-5902 Official Contact: Swaroop Patel (CEO and Co-founder) Email : spatel@zinnovi.com
Representative/Consultant:
Name : Erica Livingston, RAC Company : Qualomics LLC Address : 5938 Priestly Dr, Suite 103, Carlsbad, CA 92008 Telephone: +1 (858) 247-6804 Email: erica@qualomics.com
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.
| DescriptiveInformation | Zinnovi DUO | Brasseler GEM | VERDICT |
|---|---|---|---|
| 510(k) Number | K241649 | K221955 | NA |
| Manufacturer | Zinnovi Inc. | RealCloud Imaging Inc. doingbusiness as RealCloudImaging | NA |
| Trade Name | DUO1DUO2 | Brasseler GEM10Brasseler GEM15Brasseler GEM20 | NA |
| Classification Name | Digital X-ray Sensor | Digital X-ray Sensor | Same |
| Classification | Class II | Class II | Same |
| Classification Panel/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(1.70 M pixels) | 1539 x 1026 pixels(1.70 M pixels) | Same |
| 1692 x 1324 pixels(2.2 M Pixels) | NA | ||
| 1842 x 1324 pixels(2.40 M pixels) | 1842 x 1324 pixels(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 andWindows 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 10993-1Biocompatible | IPx8 Equivalent ISO 10993-1Biocompatible | Same |
| Indications for use | The DUO Sensors are USBdriven digital intraoral sensorswhich are intended to acquireintraoral radiographic images.The DUO Sensors shall beoperated by trainedhealthcare professionals, whoare educated and competentto perform the acquisition ofintraoral radiographs.The DUO Sensors can be usedeither in combination withspecial positioning devices tofacilitate positioning andalignment with the X-ray beamor they may also be positionedby hand with the assistance ofthe patient. | Brasseler GEM is a USBdriven digital intraoral X-raysensor which is intended toacquire dental radiographicimages.Brasseler GEM must beoperated by healthcareprofessionals who havebeen trained and arecompetent using variousmethods of acquiringradiographic images ofdental anatomy. BrasselerGEM can be used withdental positioning devicesand holders to assist withaligning an X-ray sourcebeam with the sensor andanatomy. Brasseler GEM canalso be aligned by hand withassistance of the patient. | Same |
| Intended Use | The DUO sensors are intendedfor any dental practice thatuses X-ray equipment forintraoral diagnostic purposes.DUO sensors can be used bytrained dental professionalsfor patients receiving intraoralX-ray examinations andprocedures for capturingdigital X-Ray images. Captureddigital X-ray images can beused for examinations anddiagnostic purposes with the | Brasseler GEM is intendedfor any dental practice thatuses X-ray equipment forintraoral diagnosticpurposes. Brasseler GEMcan be used by traineddental professionals forpatients receiving intraoralX-ray examinations andproduces digital images forpatients receiving intraoralX-ray examinations fordiagnostic purposes. Animage analysis software is | Same |
| help of optional image analysissoftware. | not part of this submission. | ||
| The optional image analysissoftware is not part of this | When Brasseler GEM is tobe used in a dental practice, | ||
| submission. DUO sensors canbe used with dental | an optional software will benecessary. Brasseler GEM is | ||
| positioning devices andholders to assist with aligning | a USB-driven digital intraoralX-ray sensor which is | ||
| an X-ray source beam with thesensor and anatomy. | intended to acquire dentalradiographic 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 | |||
| aligning an X-ray source | |||
| beam with the sensor and | |||
| anatomy. |
Comparison Table
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Comparison of MTF of Zinnovi DUO and MTF of Brasseler GEM
Zinnovi DUO uses a sensor component from contract manufacturer BAE Systems Imaging Solutions, a division of BAE Systems Inc., which is also responsible for the manufacture of Brasseler GEM which is the predicate device. The components used in Zinnovi DUO are the exact same components used in predicate device Brasseler GEM. The sensor MTF versus spatial frequency for Zinnovi DUO and the sensor MTF versus spatial frequency for the predicate device, Brasseler GEM, are identical.
Comparison of DQE for Zinnovi DUO and DQE of Brasseler GEM
On behalf of Zinnovi Inc., BAE Systems Imaging Solutions has compared the DQE for Zinnovi DUO with the DQE of Brasseler GEM and has determined that they are substantially equivalent to each other.
Meaningful Differences
Zinnovi DUO and Brasseler GEM are CMOS X-ray image sensors. Zinnovi has compared the MTF and the DQE of DUO sensor to the MTF and the DQE of Brasseler GEM and has determined they are substantially equivalent to each other. DUO is not only similar in performance to Brasseler GEM but is also safe and effective based on performance testing.
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Number of sensors: Zinnovi offers the smallest and largest sizes equivalent to the Brasseler GEM and would therefore be effective on the same patient population.
Operating System: Zinnovi offers device drivers to work with the latest Microsoft operating system.
X-Ray Resolution: DUO and predicate Brasseler GEM both have the same theoretical maximum resolution of 25 lp/mm.
Cable Length: Cable length has no effect on the performance of the product.
Sterilization
DUO sensors are not sold as sterile. Zinnovi Inc. recommends that usage of DUO sensor requires a hygienic barrier that meets ISO 10993 requirements for biocompatibility.
Biocompatibility
Biocompatibility testing is not needed with a rationale that considers all relevant endpoints because all materials and manufacturing/processing are identical to the predicate device, Brasseler GEM. The biocompatibility of DUO Sensors are based on the biocompatibility of the predicate device, Brasseler GEM. The DUO Sensor and the predicate Brasseler GEM are intended to be used in the oral cavity by a trained clinician.
SABIC Resin for Sensor Housing of DUO
BAE Systems Imaging Solutions uses the same SABIC resin for the sensor housing of DUO sensor that BAE Systems Imaging Solutions uses for the sensor housing of the predicate device, Brasseler GEM.
Software Information
The software for the DUO sensor consists of a simple API that can be provided to developers of existing FDA cleared image capture/dental imaging software to facilitate DUO sensor.
Risk Analysis
Zinnovi Inc. used a specified procedure for evaluating the safety of a device by identifying potential hazards and estimating the associated risks as required in the Software Design and Development Procedure subsection of the Software Information section. Zinnovi Inc. performed an extensive risk analysis of DUO sensor in accordance with the following reference standards: ISO 14971, IEC 60601-1; and IEC 60601-1-2: Medical Electrical Equipment, Part 1-2 to generate a risk analysis report.
Comparison of Safety and Effectiveness of DUO to Safety and Effectiveness of Brasseler GEM
Using the above Comparison Table, DUO sensor can be compared to the predicate device, Brasseler GEM, with respect to intended use, indications of use, environment of use, limitations of technical performance and technological characteristics and provides more detailed information regarding the basis for the
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determination of substantial equivalence. There are no differences between DUO and Brasseler GEM with respect to indications and intended use.
Performance Testing-Bench
On behalf of Zinnovi Inc, Intertek performed extensive bench testing on DUO Sensor in accordance with the following reference standards: ANSI AMI ES 60601-1 Edition 3.2 2020-08; IEC 62304 Edition 1.1 2015-06; IEC 60601-1-2 Edition 4.0 2014-02.
The results of these tests indicate that the DUO Sensor is substantially equivalent to the predicate device.
Performance Testing-Clinical
Zinnovi performed a clinical performance testing to determine that DUO performed similar or better than the predicate device, Brasseler GEM. Zinnovi has provided clinical images captured with both the devices in a performance testing report which were evaluated by US dentists. These clinical images provide evidence in addition to the bench performance data that the complete system works as intended.
Conclusion
On behalf of Zinnovi Inc., BAE Systems Imaging Solutions has compared DUO Sensor with the predicate device, Brasseler GEM, and has determined that they are substantially equivalent to each other in intended use, indications for use, safety and effectiveness, and technical characteristics.
§ 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.