(29 days)
Unknown
The summary mentions "proprietary processing software" and "Automatically optimizes the image quality," which could potentially involve AI/ML, but the document does not explicitly state the use of these technologies. Without further information or specific mention of AI/ML algorithms, it's impossible to confirm.
No
The device is described as capturing and digitizing diagnostic radiographic exposures, which is for imaging purposes, not for treating conditions.
Yes
The device is described as taking "diagnostic radiographic exposures" and providing "digital image capture" to replace film/screen, which are used for diagnosis.
No
The device description clearly states that the BIOK7600W is a "wireless digital radiography sensor" which includes a "flat panel for x-ray acquisition" and a "computer (including proprietary processing software)". This indicates the device is a combination of hardware (the sensor/flat panel and computer) and software, not software-only.
Based on the provided information, the BIOK 7600W is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information about a person's health. This testing is done outside of the body (in vitro).
- BIOK 7600W Function: The BIOK 7600W is a digital radiography sensor that captures X-ray images of the human body. It directly interacts with the patient's body by receiving X-rays that have passed through them. This is an in vivo process, not an in vitro process.
- Intended Use: The intended use clearly states it's for "taking diagnostic radiographic exposures of all body parts of the patients," which is a form of medical imaging performed directly on the patient.
Therefore, the BIOK 7600W falls under the category of medical imaging devices, not In Vitro Diagnostic devices.
N/A
Intended Use / Indications for Use
The BIOK 7600W is intended for use by a qualified doctor or technologist on both adult and pediativ for taking diagnostic radiographic exposures of all body parts of the patients. The BIOK 7600W provides digital image capture and is intended to replace radiographic film/screen. The x-ray generator, x-ray tube and associated equipment are not provided with the proposed sensor. Prescription use only.
The BIOK7600W is not intended for mammography.
Product codes
MQB
Device Description
The BIOK7600W sensor is a wireless digital radiography sensor which automatically collects x-ray images from an x-ray source. The BIOK7600W sensor (flat panel type) collects x-rays and digitizes the images for their transfer and display to a computer. The sensor does not have an x-ray source, which is provided by independent manufacturers. The sensor includes a flat panel for x-ray acquisition and a computer (including proprietary processing software) for processing, annotating and storing x-ray images.
An X-ray generator with a minimum voltage output range between 55 to 120 kVp and a minimum power of 30 KW can be used with the BIOK7600. The BIOK7600 does not connect to the generator. It automatically detects x-rays and enables the image acquisition (AEC). No changes to the generator hardware or software are required to operate the BIOK7600.
The ChiroSight software runs on a PC workstation and provides the user interface to control the BIOK7600 flat panel. ChiroSight initiates the taking of X-ray images from the BIOK7600. through the Sensor Driver application. Once an X-ray is taken. Sensor Driver reads it from the flat panel and transfers it to ChiroSight. After it receives an image from the BIOK7600, ChiroSight:
Automatically optimizes the image quality Permanently stores the image to its database Displays the image to the user Allows the user to perform image manipulations and to add annotations Allows the user store and transfer the images in DICOM format.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
x-ray
Anatomical Site
all body parts
Indicated Patient Age Range
adult and paediatric
Intended User / Care Setting
qualified doctor or technologist
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
A set of test images have been submitted along with the equivalent images from the predicate device.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
a. Non-clinical considerations: the non-clinical considerations document demonstrates that the BIOK7600W sensor offers equivalent performance, biocompatibility, effectiveness, thermal, electrical and mechanical safety and is equivalent to the predicate device. The design, development and production of the sensor conforms to 892.1680 and ISO 13485 quality systems.
b. Clinical considerations concurrence study: A set of test images have been submitted along with the equivalent images from the predicate device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Wireless Digital Flat Panel Detector (K182551)
Reference Device(s)
BIOK4600 Digital Radiography Sensor (K092307), Aquarius 8600 Flat Panel Detector (K181565)
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.
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March 13, 2019
Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: on the left, there is a seal with an eagle, and on the right, there is the text "FDA U.S. FOOD & DRUG ADMINISTRATION" in blue. The text is arranged in two lines, with "FDA" on the first line and "U.S. FOOD & DRUG ADMINISTRATION" on the second line.
Biokinemetrics Inc. % Steven Kraus President 211 East 4th Street CARROLL IOWA 51401
Re: K190300
Trade/Device Name: BIOK7600W Wireless Flat Panel Detector Regulation Number: 21 CFR 892.1680 Regulation Name: Stationary x-ray system Regulatory Class: Class II Product Code: MQB Dated: February 9, 2019 Received: February 12, 2019
Dear Steven Kraus:
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.
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): medical device reporting (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
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https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.
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/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Michael D. O'Hara
For
Thalia Mills, Ph.D. Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K190300
Device Name BIOK7600W Wireless Flat Panel Detector
Indications for Use (Describe)
The BIOK 7600W is intended for use by a qualified doctor or technologist on both adult and pediativ for taking diagnostic radiographic exposures of all body parts of the patients. The BIOK 7600W provides digital image capture and is intended to replace radiographic film/screen. The x-ray generator, x-ray tube and associated equipment are not provided with the proposed sensor. Prescription use only.
The BIOK7600W is not intended for mammography.
| 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 shows the logo for Biokinemetrics. The logo is in blue and green, with the word "BIOKINE" in blue and the "ME" in green. Below the logo is the tagline "ALIGNING CHIROPRACTIC AND TECHNOLOGY" in a smaller font.
TRADITIONAL 510K - SUMMARY (K190300)
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- Device type and name: BIOK7600W Wireless Flat Panel Detector
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- Submitter Biokinemetrics Inc. 211 East 4th Street Carroll lowa 51401
- Dr. Steven Kraus Contact person: President Tel: (712) 210-4750 Fax: (888) 800-2149 e-mail: skraus@biokinemetrics.com
Date prepared: March 7, 2019
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- Device name: BIOK7600W Wireless Flat Panel Detector BIOK7600W Common name:
- Class II, 21 CFR 892.1680, Solid-State X-ray Imager (Flat panel/ 4. Device classification: Digital Imager)
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- Product Code: 90MQB
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- Requlation Name: Stationary x-ray system
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- Basis for the submission: Addition of a sensor to the list of medical devices compatible with the Biokinemetrics devices
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- Device description: The BIOK7600W sensor is a wireless digital radiography sensor which automatically collects x-ray images from an x-ray source. The BIOK7600W sensor (flat panel type) collects x-rays and digitizes the images for their transfer and display to a computer. The sensor does not have an x-ray source, which is provided by independent manufacturers. The sensor includes a flat panel for x-ray acquisition and a computer (including proprietary processing software) for processing, annotating and storing x-ray images.
An X-ray generator with a minimum voltage output range between 55 to 120 kVp and a minimum power of 30 KW can be used with the BIOK7600. The BIOK7600 does not connect to the generator. It automatically detects x-rays and enables the image acquisition (AEC). No changes to the generator hardware or software are required to operate the BIOK7600.
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Image /page/4/Picture/0 description: The image is a logo for Biokinemetrics. The logo is blue and green, with the word "BIOKINETRICS" in large, bold letters. Below the word is the tagline "ALIGNING CHIROPRACTIC AND TECHNOLOGY" in smaller letters. The logo is simple and modern, and it conveys the company's focus on chiropractic and technology.
The ChiroSight software runs on a PC workstation and provides the user interface to control the BIOK7600 flat panel. ChiroSight initiates the taking of X-ray images from the BIOK7600. through the Sensor Driver application. Once an X-ray is taken. Sensor Driver reads it from the flat panel and transfers it to ChiroSight. After it receives an image from the BIOK7600, ChiroSight:
Automatically optimizes the image quality Permanently stores the image to its database Displays the image to the user Allows the user to perform image manipulations and to add annotations Allows the user store and transfer the images in DICOM format.
The software level of concern for the BIOK7600 has been determined to be moderate based on the "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices.
The cybersecurity risks of the BIOK7600 have been addressed to assure that no new or increased cybersecurity risks were introduced as a part of device risk analysis. These risks are defined as sequence of events leading to a hazardous situation, and the controls for these risks were treated and implemented as proposed in the risk analysis (e.g., requirements, verification).
- The BIOK7600W is intended for use by a qualified doctor or 10. Indications for use: technologist on both adult and paediatric patients for taking diagnostic radiographic exposures of all body parts of the patients. The BIOK7600W is not intended for mammography.
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- Comparison with predicate devices: The BIOK7600W sensor is composed of a flat panel detector very similar to the technology used in the Wireless Digital Flat Panel Detector (K182551, predicate device hardware) and the BIOK4600 (K092307) software on the PC. The hardware and firmware of the BIOK7600W sensor are considered to be substantially equivalent to the predicate device hardware, as demonstrated in the non-clinical considerations document, based on the SSXI Guidance from FDA. The BIOK7600W software functionality is equivalent to the original BIOK4600 reference device, except for the Imaray interface application which reads the images from the new BIOK7600W sensor instead of the BIOK 4600 sensor. The BIOK7600W produces images of similar quality and characteristics that are equivalent to those of the predicate device, as demonstrated in the clinical considerations - concurrence study provided in this submission.
- a. Non-clinical considerations: the non-clinical considerations document demonstrates that the BIOK7600W sensor offers equivalent performance, biocompatibility, effectiveness, thermal, electrical and mechanical safety and is equivalent to the predicate device. The design, development and production of the sensor conforms to 892.1680 and ISO 13485 quality systems.
- b. Clinical considerations concurrence study: A set of test images have been submitted along with the equivalent images from the predicate device.
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Image /page/5/Picture/0 description: The image shows the logo for Biokinemetrics. The logo is in blue and green, with the word "BIOKINE" in blue and "METRICS" in green. Below the logo is the tagline "ALIGNING CHIROPRACTIC AND TECHNOLOGY" in a smaller font.
- c. Conclusion: the device was evaluated against the predicate device (Wireless Digital Flat Panel Detector, K182551) and was found to be equivalent to the predicate device.