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K Number
K200622
Device Name
Focus 43C detector, TRIMAX 43C detector
Manufacturer
iRay Technology Taicang Ltd.
Date Cleared
2020-04-01

(23 days)

Product Code
MQB
Regulation Number
892.1680
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Focus 43C and TRIMAX 43C are indicated for digital imaging solutions designed to provide general radiographic diagnosis for human anatomy including both adult and pediatric patients. They are intended to replace film/screen systems in all general-purpose diagnostic procedures. These two devices are not intended for mammography, dental applications.
Device Description
Focus 43C Detector and TRIMAX 43C Detector (Hereinafter referred to as Focus 43C and TRIMAX 43C) are a kind of wireless digital flat panel detectors. They support the single frame mode, with the key component of TFT/PD image sensor flat panel of active area: 427mm x 427mm. Two models TRIMAX 43C and Focus 43C are totally same except for label and trademark. The sensor plate of Focus 43C and TRIMAX 43C detectors are direct-deposited with CsI scintillator to achieve the conversion from X-ray to visible photon. The visible photons are transformed to electron signals by diode capacitor array within TFT panel, which are composed and processed by connecting to scanning and readout electronics, consequently to form a panel image by transmitting to PC through the user interface. The major function of the Focus 43C and TRIMAX 43C detectors are to convert the X-ray to digital image, with the application of high-resolution X-ray imaging. This kind of detector is the key component of DR system, enables to complete the digitalization of the medical X-ray imaging with the DR system software. iRay SDK(include iDetector) is intend to supply API interface for DR system manufacturers.
More Information

K183713

Not Found

No
The document describes a standard digital X-ray detector that converts X-rays to digital images. It mentions image processing but does not include any terms or descriptions related to AI, ML, training data, or performance metrics typically associated with AI/ML algorithms.

No
The device is described as being for "digital imaging solutions designed to provide general radiographic diagnosis," and its major function is to "convert the X-ray to digital image." It is a diagnostic device, not a therapeutic one.

Yes

The "Intended Use / Indications for Use" section explicitly states that the devices "are indicated for digital imaging solutions designed to provide general radiographic diagnosis for human anatomy."

No

The device description explicitly states that the Focus 43C and TRIMAX 43C are "wireless digital flat panel detectors" with a "TFT/PD image sensor flat panel" and "CsI scintillator," which are physical hardware components. The device's primary function is to convert X-ray to a digital image, which is a hardware-based process. While it interacts with software (DR system software and iRay SDK), it is fundamentally a hardware device.

Based on the provided text, this device is not an IVD (In Vitro Diagnostic).

Here's why:

  • Intended Use: The intended use is for "digital imaging solutions designed to provide general radiographic diagnosis for human anatomy". This involves capturing images of the body using X-rays.
  • Device Description: The device is a "wireless digital flat panel detector" that converts X-rays into digital images. It's a component of a DR (Digital Radiography) system.
  • IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.

This device operates externally to the body and is used for imaging, not for analyzing biological samples. Therefore, it falls under the category of medical imaging devices, not IVDs.

N/A

Intended Use / Indications for Use

Focus 43C and TRIMAX 43C are indicated for digital imaging solutions designed to provide general radiographic diagnosis for human anatomy including both adult and pediatric patients. They are intended to replace film/screen systems in all general-purpose diagnostic procedures. This device is not intended for mammography, dental applications.

Product codes

MQB

Device Description

Focus 43C Detector and TRIMAX 43C Detector (Hereinafter referred to as Focus 43C and TRIMAX 43C) are a kind of wireless digital flat panel detectors. They support the single frame mode, with the key component of TFT/PD image sensor flat panel of active area: 427mm x 427mm. Two models TRIMAX 43C and Focus 43C are totally same except for label and trademark.

The sensor plate of Focus 43C and TRIMAX 43C detectors are direct-deposited with CsI scintillator to achieve the conversion from X-ray to visible photon. The visible photons are transformed to electron signals by diode capacitor array within TFT panel, which are composed and processed by connecting to scanning and readout electronics, consequently to form a panel image by transmitting to PC through the user interface. The major function of the Focus 43C and TRIMAX 43C detectors are to convert the X-ray to digital image, with the application of high-resolution X-ray imaging. This kind of detector is the key component of DR system, enables to complete the digitalization of the medical X-ray imaging with the DR system software. iRay SDK(include iDetector) is intend to supply API interface for DR system manufacturers.

DR system manufacturer control the detector by SDK interface. SDK is not intended to be used directly by other users beside DR system manufacturers. The iRay SDK is unchanged from the predicate device.

Mentions image processing

Yes

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

X-ray

Anatomical Site

human anatomy

Indicated Patient Age Range

adult and pediatric patients

Intended User / Care Setting

Not Found

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)

Non-clinical studies were performed, and the results showed substantial equivalence to the predicate device regarding non-clinical considerations. No significant difference was observed between images from the Focus 43C/TRIMAX 43C and the predicate device. Clinical consideration may not be necessary for changes in pixel size, resolution, or wireless functionality if non-clinical information supports substantial equivalence.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s)

K183713

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

§ 892.1680 Stationary x-ray system.

(a)
Identification. A stationary x-ray system is a permanently installed diagnostic system intended to generate and control x-rays for examination of various anatomical regions. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II (special controls). A radiographic contrast tray or radiology diagnostic kit intended for use with a stationary x-ray system only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.

0

Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left, there 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.

iRay Technology Taicang Ltd. % Meng Li Registration & Regulation Affairs Engineer No. 33 Xinggang Rd., Taicang Port Economic & Technological Development Zone Taicang, Jiangsu 215434 CHINA

Re: K200622

Trade/Device Name: Focus 43C Detector, TRIMAX 43C Detector Regulation Number: 21 CFR 892.1680 Regulation Name: Stationary x-ray system Regulatory Class: Class II Product Code: MQB Dated: February 14, 2020 Received: March 9, 2020

Dear Meng Li:

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.

April 1, 2020

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.

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

1

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 medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

For

Thalia T. Mills, Ph.D. Director Division of Radiological Health OHT7: Office of In Vitro Diagnostics and Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

2

Indications for Use

510(k) Number (if known) K200622

Device Name Focus 43C Detector TRIMAX 43C Detector

Indications for Use (Describe)

Focus 43C and TRIMAX 43C are indicated for digital imaging solutions designed to provide general radiographic diagnosis for human anatomy including both adult and pediatric patients. They are intended to replace film/screen systems in all general-purpose diagnostic procedures. These two devices are not intended for mammography, dental applications

There are no differences between the 2 models except the model name and trade mark.

TVDE of USe (Select One of Doll). as applicable)
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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3

SECTION 6

510 (k) SUMMARY OF SAFETY AND EFFECTIVENESS

SECTION 6 - 1 of 12

4

510 (k) SUMMARY OF SAFETY AND EFFECTIVENESS K200622

(As Required by 21 CFR 807.92)

1. Date Prepared [21 CFR 807.92(a)(1)]

Jan. 8th, 2020

2. Submitter's Information [21 CFR 807.92(a)(1)]

Company Name:iRay Technology Taicang Ltd.
Company Address:No.33 Xinggang Road, Taicang Port Economic and
Technological Development Zone, Jiangsu, China 215434
Contact Person:Junjie Qian
Phone:0512-53690872
Fax:0512-53690872
Email:junjie.qian@iraygroup.com

3. Trade Name, Common Name, Classification [21 CFR 807.92(a)(2)]

| Trade Name: | Focus 43C Detector
TRIMAX 43C Detector |
|----------------------|-------------------------------------------|
| Common Name: | Solid State X-Ray Imager |
| Model Name: | Focus 43C
TRIMAX 43C |
| Classification Name: | Stationary x-ray system |
| Product Code: | MQB |
| Regulation Number: | 21 CFR 892.1680 |
| Device Class: | Class II |

SECTION 6 - 2 of 12

5

4. Identification of Predicate Devices(s) [21 CFR 807.92(a)(3)[

The identification predicates within this submission are as follows:

Manufacturer:iRay Technology Taicang Ltd.
Trade Name:Wireless Digital Flat Panel Detector
Model Name:Mars1717XF-CSI
Product Code:MQB
Device Class:Class II
Classification Name:Stationary x-ray system
FDA 510 (k) #:K183713

5. Description of the Device [21 CFR 807.92(a)(4)]

Focus 43C Detector and TRIMAX 43C Detector (Hereinafter referred to as Focus 43C and TRIMAX 43C) are a kind of wireless digital flat panel detectors. They support the single frame mode, with the key component of TFT/PD image sensor flat panel of active area: 427mm x 427mm. Two models TRIMAX 43C and Focus 43C are totally same except for label and trademark.

The sensor plate of Focus 43C and TRIMAX 43C detectors are direct-deposited with CsI scintillator to achieve the conversion from X-ray to visible photon. The visible photons are transformed to electron signals by diode capacitor array within TFT panel, which are composed and processed by connecting to scanning and readout electronics, consequently to form a panel image by transmitting to PC through the user interface. The major function of the Focus 43C and TRIMAX 43C detectors are to convert the X-ray to digital image, with the application of high-resolution X-ray imaging. This kind of detector is the key component of DR system, enables to complete the digitalization of the medical X-ray imaging with the DR system software. iRay SDK(include iDetector) is intend to supply API interface for DR system manufacturers.

DR system manufacturer control the detector by SDK interface. SDK is not intended to be used directly by other users beside DR system manufacturers. The iRay SDK is unchanged from the predicate device.

SECTION 6 - 3 of 12

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6. Intended Use [21 CFR 807.92(a)(5)]

6.1. Indications for use

Focus 43C and TRIMAX 43C are indicated for digital imaging solutions designed to provide general radiographic diagnosis for human anatomy including both adult and pediatric patients. They are intended to replace film/screen systems in all general-purpose diagnostic procedures. This device is not intended for mammography, dental applications. There are no differences between the 2 models except the model name and trade mark.

6.2. Suitable patient

They are suitable for providing digital X-ray imaging for DR system to provide general radiographic diagnosis for human anatomy including both adult and pediatric patients, but not intended for mammography or dental applications. The remaining notes depend on the DR system.

6.3. Processing of input and output

When flat panel detector works continuously, it can automatically distinguish Xray and output an imaging for diagnosis of disease, injury, or of any applicable health problem.

| Item | Predicate Device:
Wireless Digital Flat Panel
Detector | Proposed Device:
Wireless Digital Flat Panel
Detector |
|----------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(K)
Number | K183713 | K200622 |
| Intended Use | The Mars1717XF-CSI Wireless
Digital Flat Panel Detector is
indicated for digital imaging | same |
| Item | Predicate Device:
Wireless Digital Flat Panel
Detector | Proposed Device:
Wireless Digital Flat Panel
Detector |
| | solution designed for providing
general radiographic system in all
general-purpose diagnostic
procedures. | |
| Indications
for
Use | Mars1717XF-CSI Wireless
Digital Flat Panel Detector is
indicated for digital imaging
solution designed for providing
general radiographic diagnosis of
human anatomy.

It is intended to replace
radiographic film/screen systems
in all general-purpose diagnostic
procedures. This device is not
intended for mammography or
dental applications.

We understand the Agency has
become aware of situations where
solid state detectors inserted into
radiographic systems adversely
impacted device performance due
to improper integration
(reference:http://www.fda.gov/do
wnloads/MedicalDevices/Resourc | Same with Mars1717XF-CSI,
additionally, in the
consideration of patient size
(i.e., height, weight, body part
thickness) and usable dose
range, the detector could be
used for general X ray
diagnosis of usual body part
for adults and pediatric
patients.
. |
| | Predicate Device: | Proposed Device: |
| Item | Wireless Digital Flat Panel | Wireless Digital Flat Panel |
| | Detector | Detector |
| | esforYou/Industry/UCM385149.p | |
| | df ). | |
| | | |
| | Below is a summary of the | |
| | information from the | |
| | Mars1717XF-CSI user manuals | |
| | covering key electromechanical | |
| | and computer requirements | |
| | needed for X-ray system interface | |
| | and integration. | |
| | 1. Mechanical interface | |
| | requirements. | |
| | 2. Computer requirements | |
| | 3. Data communication interface | |
| | requirements | |
| | 4. Electrical power requirements | |
| | 5. X-ray trigger interface | |
| | requirements | |
| | | |
| | Neither the Mars1717XF-CSI | |
| | detector nor its software act as an | |
| | X-ray generator controller, and | |
| | therefore, the device is not subject | |
| | to Electronic Product Radiation | |
| | Control (EPRC) performance | |
| | standards and reporting | |
| | requirements. | |
| | Predicate Device: | Proposed Device: |
| Item | Wireless Digital Flat Panel Detector | Wireless Digital Flat Panel Detector |
| Classification Name | Stationary x-ray system | Same |
| Product Code | MQB | Same |
| Regulation Number | 21 CFR 892.1680 | Same |
| Panel: | Radiology | Same |
| Classification: | II | Same |
| X-Ray Absorber (Scintillator): | CsI | Same |
| Installation Type: | Wireless, Portable | Same |
| Readout Mechanism: | Thin Film Transistor | Same |
| Image Matrix Size: | 2832× 2836 pixels | 3072 × 3072 pixels |
| Pixel Pitch: | 150μm | 139µm |
| ADC Digitization | 16 bit | Same |
| Effective Imaging Area: | 424.8 mm × 425.4 mm | 427 mm × 427 mm |
| Spatial Resolution: | 3.3lp/mm | 3.6lp/mm |
| Modulation Transfer Function (MTF) | 0.49 at 1 lp/mm | 0.61 at 1 lp/mm |
| | Predicate Device: | Proposed Device: |
| Item | Wireless Digital Flat Panel
Detector | Wireless Digital Flat Panel
Detector |
| Detective
Quantum
Efficiency
(DQE) | 0.40 at 1 lp/mm (RQA5, 2.5µGy) | 0.46 at 1 lp/mm (RQA5, 2.5µGy) |
| Power
Consumption: | Max. 20W | Max. 20W |
| Communication
s:
(Wireless
functionality) | Wireless: IEEE 802.11a/b/g/n (2.4 GHz / 5 GHz) | a) Wired (only for service) : Gigabit
Ethernet (1000BASE-T)
b) Wireless: IEEE
802.11a/b/g/n/ac (2.4 GHz / 5 GHz) |
| | Imaging protect
Plate: | Carbon Fiber Plate |
| Cooling: | Air cooling | Same |
| Dimensions: | 460 mm × 460 mm × 15 mm | 460 mm × 460 mm × 15.2 mm |
| Operation: | Temperature: +5 ~ +30 °C | Temperature: +5 ~ +35 °C |
| | Humidity: 10 ~ 80%
(Non-Condensing) | Humidity: 10 ~ 90%
(Non-Condensing) |
| | Atmospheric pressure: 70 ~ 106 kPa | Atmospheric pressure: 70 ~ 106 kPa |
| | Altitude: Max. 3000 meters | Altitude: Max. 3000 meters |
| Storage and
Transportation: | Temperature: -20 ~ +50 °C
Humidity: 10 ~ 90% | Temperature: -20 ~ +55 °C
Humidity: 5 ~ 95% |
| | Predicate Device: | Proposed Device: |
| Item | Wireless Digital Flat Panel | Wireless Digital Flat Panel |
| ( detector ) | Detector | Detector |
| | (Non-Condensing) | (Non-Condensing) |
| | Atmospheric pressure: 70 ~ 106 kPa | Atmospheric pressure: 70 ~ 106 kPa |
| | Altitude: Max. 3000 meters | Altitude: Max. 3000 meters |
| | iRay SDK(include iDetector) is | |
| | intend to supply API interface for | |
| | DR system manufacturers. DR | |
| Software | system manufacturer control the detector by SDK interface. SDK is not intended to use directly by other users beside DR system manufacturers. | Same |
| | 1. Guidance for the Submission of 510(k)'s for Solid State X-ray Imaging Devices; | |
| | 2. The 510(k) Program:
Evaluating Substantial
Equivalence in Premarket
Notifications[510(k)]; | Same with Mars1717XF-CSI, additionally:
Guidance for "Premarket Assessment of Pediatric Medical Devices";
Guidance for "Pediatric Information for X-ray Imaging Device Premarket Notifications". |
| Utilized FDA
guidance
documents | 3. Content of Premarket
Submissions for Management
of Cybersecurity in Medical
Devices;
4. Radio Frequency Wireless
Technology in Medical
Devices. | |

7. Technological Characteristic [21 CFR 807.92(a)(6)]

SECTION 6 - 4 of 12

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SECTION 6 - 5 of 12

8

SECTION 6 - 6 of 12

9

iRay Technology Taicang Ltd.

[510(k)] Application

SECTION 6 - 7 of 12

10

SECTION 6 - 8 of 12

11

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12

8. System requirements to operate with other radiographic system components

    1. Recommended Generator Specification:
      Energy range: 40~150keV

mA range: 10~1000mA (depending on the generator power)

ms range: 106300ms to produce 0.11000mAs (depending on the generator power) Note: To our best knowledge, the detector is compatible with the X-ray generators with the specifications described above. If you have any questions regarding the compatibility issue for other generators, please contact your distributor or iRay's service office.

    1. Application Program Interface (API) for system integration manufacturer Peripheral hardware: Focus 43C and TRIMAX 43C detectors connected via wireless communication.
      Minimum computer hardware requirement is:

  • Windows 10 Professional 64 bit

  • Intel Core(TM)2 Duo CPU E7400 @ 2.80GHz or equivalent AMD CPU

  • 4GB DRAM memory

  • · 200GB hard disk

  • · Ethernet card 100 Mbp/s (Dual Ethernet cards required)

  • CD/DVD writer

  • 17" display of 1280x800 resolution.

  • 2 USB ports

    1. X-ray exposure mode

The AED trigger module is a unit can connect X-ray signal in the Focus 43C and TRIMAX 43C. Once there is X-ray generator exposure exist, the inner trigger module will detect the X-ray radiation and output signal to the detector. Until the exposure finished, the detector will receive a signal which represent the end of exposure from the inner trigger module and begin to acquire the image.

SECTION 6 - 10 of 12

13

9. Substantial Equivalence [21 CFR 807.92(b)(1) and 807.92(b)(2)]

    1. Electrical Safety and EMC testing:
      Electrical, mechanical, environmental safety and performance testing according to IEC/ES 60601-1 was performed, and EMC testing was also conducted in accordance with IEC 60601-1-2. All test results are meet the standard requirements.
    1. Biological Evaluation:
      The materials of the detector which contact operators' or patient's skin have been evaluated with the ISO 10993-1. And the evaluation results and test result assured the safety the same as the predicate device.
    1. Non-clinical Considerations:
      One modification from the predicate device to Focus 43C and TRIMAX 43C is geometric design, related to Amorphous Silicon (A-Si) panel size and structure size design. Another modification is wireless functionality, predicate device has higher wireless transmission speed.

The non-clinical studies have been performed and the results have shown that sections of the non-clinical consideration mentioned in the 'Guidance for the Submission of 510(k)s for Solid State X-ray Imaging Devices' are substantially equivalent to the non-consideration of predicate devices on the Market (Mars1717XF-CSI, K183713).

    1. Clinical Consideration:
      Intended use, fundamental scientific technology, regulatory requirement, non-clinical performance, labeling, quality-assurance program and software keep the same with those of predicate device. Additionally, as mentioned in clinical considerations in 'Guidance for the Submission of 510(k)s for Solid State X-ray Imaging Devices', clinical consideration may not necessary for changes in the pixel size and resolution with the same x-ray detection material and may not necessary for changes in the wireless functionality if non-clinical information is sufficient to support the substantial equivalence.

There was no significant difference between the images of the Focus 43C/TRIMAX 43C and those of the predicate device.

SECTION 6 - 11 of 12

14

10. Conclusion [21 CFR 807.92(b)(3)]

In accordance with the Federal Food, Drug and Cosmetic Act, 21 CFR Part 807 and based on the information provided in this premarket notification, iRay Technology Taicang Ltd. concludes that Focus 43C and TRIMAX 43C are substantially equivalent to predicate device with regards to safety and effectiveness.

SECTION 6 - 12 of 12