(29 days)
Not Found
No
The document describes standard digital radiography image processing and storage, with no mention of AI, ML, or related concepts. The performance studies focus on equivalence to a predicate device based on hardware and image comparison, not on algorithmic performance metrics typically associated with AI/ML.
No.
The device is intended for diagnostic radiographic exposures and digital image capture, not for treating diseases or conditions.
Yes
Explanation: The "Intended Use / Indications for Use" section states that the device is for "taking diagnostic radiographic exposures of all body parts," indicating its role in diagnosis.
No
The device description explicitly states that the device includes a "flat panel for x-ray acquisition and digitization" and a "computer (including proprietary processing software)". This indicates the presence of significant hardware components beyond just software.
Based on the provided information, the AQUARIUS 8600 is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use clearly states that the device is for "taking diagnostic radiographic exposures of all body parts" and "provides digital image capture." This describes an imaging device used to visualize internal structures of the body, not a device used to examine specimens derived from the human body (like blood, urine, tissue, etc.) outside of the body.
- Device Description: The description reinforces this by stating it's a "digital radiography sensor" that "collects x-ray images from an x-ray source." This is consistent with medical imaging, not in vitro diagnostics.
- Input Imaging Modality: The input modality is "x-ray," which is a form of medical imaging, not a method used for in vitro diagnostic testing.
IVD devices are specifically designed to perform tests on samples taken from the human body to provide information for diagnosis, monitoring, or screening. The AQUARIUS 8600's function is to capture images of the body itself using x-rays.
N/A
Intended Use / Indications for Use
The AQUARIUS 8600 is intended for use by a qualified doctor or technologist on both adult and paediatric patients for taking diagnostic radiographic exposures of all body parts of the AQUARIUS 8600 provides digital image capture and is intended to replace radiographic film/screen. The x-ray tube and associated equipment are not provided with the proposed sensor. Prescription use only.
The AQUARIUS 8600 is not intended for mammography.
Product codes
MOB, MQB
Device Description
The Aquarius 8600 is a digital radiography sensor which automatically collects x-ray images from an x-ray source. The Aquarius 8600 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 with a flat panel for x-ray acquisition and digitization 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 Aquarius 8600. The Aquarius 8600 does not connect to the generator. It automatically detects x-rays and enables the image acquisition. No changes to the generator hardware or software are required to operate the Aquarius 8600.
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 patients
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
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-clinical tests: Because the sensor hardware is the same as the Aquarius 8600 predicate device hardware, the sensor has the same performance, biocompatibility, effectiveness, thermal, electrical and mechanical safety and is substantially equivalent to the predicate device. The design, development and production of the sensor conforms to 892.1680 and ISO 13485 quality systems.
Image Comparison: Test images have been submitted along with the equivalent images from the Aquarius 8600 predicate device.
Conclusion: the device was evaluated against both predicate devices (BIOK4600 and Aquarius 8600) and was found to be substantially equivalent to the predicate devices.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
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.
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Image /page/0/Picture/0 description: The image shows the logos of the Department of Health & Human Services and the Food and Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
July 13, 2018
Biokinemetrics Inc. % Steven Kraus President 211 East 4th Street CARROLL IA 51401
Re: K181565
Trade/Device Name: AQUARIUS 8600 Digital Radiography Sensor Regulation Number: 21 CFR 892.1680 Regulation Name: Stationary x-ray system Regulatory Class: II Product Code: MOB Dated: June 13, 2018 Received: June 14, 2018
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. 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); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820);
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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,
Hol 2. Nils
Robert Ochs, 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) K181565
Device Name AQUARIUS 8600 Digital Radiography Sensor
Indications for Use (Describe)
The AQUARIUS 8600 is intended for use by a qualified doctor or technologist on both adult and paediatric patients for taking diagnostic radiographic exposures of all body parts of the AQUARIUS 8600 provides digital image capture and is intended to replace radiographic film/screen. The x-ray tube and associated equipment are not provided with the proposed sensor. Prescription use only.
The AQUARIUS 8600 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 "METRICS" in green. Below the logo is the tagline "ALIGNING CHIROPRACTIC AND TECHNOLOGY" in a smaller blue font. The logo is simple and modern, and the tagline is clear and concise.
SPECIAL 510K - SUMMARY OF SAFETY AND EFFECTIVENESS
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- Device type and name: Aquarius 8600 Digital Radiography Sensor Common name: Aquarius 8600
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- Submitter Biokinemetrics Inc. 211 East 4th Street Carroll lowa 51401
- Contact person: Dr. Steven Kraus President Tel: (712) 210-4750 Fax: (888) 800-2149 e-mail: skraus@biokinemetrics.com
June 12, 2018 Date prepared:
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- Device classification: 21 CFR 892.1680, Stationary x-ray system
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- Product Code: 90/MQB
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- Basis for the submission: Software modifications to support Aquarius 8600 Flat Panel Detector.
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- Device description: The Aquarius 8600 is a digital radiography sensor which automatically collects x-ray images from an x-ray source. The Aquarius 8600 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 with a flat panel for x-ray acquisition and digitization 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 Aquarius 8600. The Aquarius 8600 does not connect to the generator. It automatically detects x-rays and enables the image acquisition. No changes to the generator hardware or software are required to operate the Aquarius 8600.
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Image /page/4/Picture/0 description: The image shows the logo for Biokinemetrics. The logo is in blue and green, with the word "BIOKINEMETRICS" 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.
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- Indications for use: The Aquarius 8600 is intended for use by a qualified doctor or technologist on both adult and paediatric patients for taking diagnostic radiographic exposures of all body parts of the patients. The Aquarius 8600 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 Aquarius 8600 is not intended for mammography.
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- Comparison with predicate devices: The Aquarius 8600 is composed of the Aquarius 8600 predicate device hardware and the BIOK4600 software on the PC. The hardware and firmware of the Aquarius 8600 flat panel is UNMODIFIED and is considered to be substantially equivalent to the Aquarius 8600 predicate device hardware. The Aquarius 8600 software functionality is equivalent to the original BIOK4600 predicate device, except for the Sensor Driver interface application which reads the images from the Aquarius 8600 flat panel instead of the BIOK 4600 sensor. The Aquarius 8600 produces images of similar quality and characteristics that are equivalent to those of the both the Aquarius 8600 and BIOK4600 predicate devices.
- a. Non-clinical tests: Because the sensor hardware is the same as the Aquarius 8600 predicate device hardware, the sensor has the same performance, biocompatibility, effectiveness, thermal, electrical and mechanical safety and is substantially equivalent to the predicate device. The design, development and production of the sensor conforms to 892.1680 and ISO 13485 quality systems.
- b. Image Comparison: Test images have been submitted along with the equivalent images from the Aquarius 8600 predicate device.
- C. Conclusion: the device was evaluated against both predicate devices (BIOK4600 and Aquarius 8600) and was found to be substantially equivalent to the predicate devices.
| X-Ray Equipment
| (Generator, Tube) | Not provided by Biokinemetrics |
|---|---|
| Flat Panel Sensor | AQUARIUS 8600 Flat Panel |
| Detector array size: 17" x 17" | |
| (423mm x 423mm) | |
| TFT matrix: (3328 x 3328 pixels) | |
| Flat Panel Sensor | Spatial resolution: 3.9 lp/mm |
| Optical resolution: 3.9 lp/mm | |
| Acquisition to display time: |